Asthma
Conditions
Keywords
Asthma, alternative medicine, complementary medicine, herbal therapy
Brief summary
The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics
Detailed description
Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies. We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.
Interventions
DRUGASHMI 4
4 capsules orally twice a day
DRUGASHMI 12
12 capsules orally twice a day
DRUGPlacebo
Placebo 6 capsules twice a day
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects ages 18 through 55 and otherwise in good health as determined by medical history and physical examination * History of asthma documented by a physician for at least 6 months * Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study * The subject agrees to participate in the study * Subjects must have one of the following: * one asthma-related unscheduled visit to an Emergency Department or clinic in the past 12 months * One overnight hospitalization in the past 12 months * Disturbed sleep more than twice in the past month * Asthma symptoms ≥8 times in the past month * use of a β2-agonist ≥8 times in the past month * two short courses (3-7 days) of oral corticosteroids in the last 12 months * FEV1 \<80% predicted AND Use of inhaled corticosteroid (ICS) for at least 1 month prior to enrollment
Exclusion criteria
* Acute illness (such as cold, flu, etc.) within two weeks before the screening visit * Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including hepatitis virus infection * History of chronic obstructive lung disease, emphysema, or other chronic respiratory condition * Abnormal hepatic function (ALT/AST and bilirubin \>1.25 x upper limit of normal) * Abnormal bone marrow function (WBC \<4 x 103/mm3; platelets \<100 x 103/mm3; Hgb \<11 g/dl) * Abnormal renal function (BUN and creatinine \>1.25 x upper limit of normal) * Clinically significant abnormal electrocardiogram * FEV1 \<50% predicted * Participation in another experimental therapy study within 30 days of this study * History of alcohol or drug abuse * Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study * Subjects receiving treatment with Omalizumab or immunotherapy for asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose, Urea and Creatinine Phase I | 1 week after receiving active drug or placebo | Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1 |
| Sodium, Potassium, Chloride and CO2 Phase I | 1 week after receiving active drug or placebo | Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1 |
| Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | 1 week after receiving active drug and placebo | Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1 |
| Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | 1 week after receiving active drug and placebo | Summary of Laboratory data for White Blood Cell(cells\*10\^3/uL), Hemoglobin(cells\*10\^3/uL) and Platelet(cells\*10\^3/uL)in subjects enrolled in Phase 1 |
| Hemoglobin Laboratory Results in Phase I | 1 week | Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1 |
| Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | 28 weeks | Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment |
| Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | 28 weeks | Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment |
| Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | 28 weeks | Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment |
| Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | 28 weeks | Summary of Laboratory data for White Blood Cell Count(cells\*10\^3/uL) and Platelet (cells\*10\^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment |
| Laboratory Results for Hemoglobin in Subjects in Phase II Study | 28 weeks | Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 10/5/2006-3/12/2010 Location: Mount Sinai School of Medicine, New York, NY Phase I Participants Screened 55 Consented 35 Excluded 13 Withdrawn 2 Phase II Participants Screened 183 Consented 76 Excluded 19 Screen failed 11
Pre-assignment details
Phase I: Time frame 1 week; Phase II: Time frame 28 weeks. Participants from Phase I were invited to participate in Phase II and were re-randomized to all three arms of Phase II.
Participants by arm
| Arm | Count |
|---|---|
| Active, Phase I Patients received 3 daily doses in which 2, 4, or 6 ASHMI capsules were administered twice a day for 7 days. | 12 |
| Placebo, Phase I Patients received placebo. | 8 |
| Active, Phase II (ASHMI 4 Caps ) Patients received active drug, 4 caps twice a day | 15 |
| Active, Phase II (ASHMI 12 Caps) Patients received active drug, 12 caps twice a day | 16 |
| Placebo, Phase II Patients received placebo. | 15 |
| Total | 66 |
Baseline characteristics
| Characteristic | Active, Phase I | Placebo, Phase I | Total | Active, Phase II (ASHMI 4 Caps ) | Active, Phase II (ASHMI 12 Caps) | Placebo, Phase II |
|---|---|---|---|---|---|---|
| Age, Continuous Phase 1 | 32 years STANDARD_DEVIATION 7 | 31 years STANDARD_DEVIATION 9 | 31.6 years STANDARD_DEVIATION 8.06 | — | — | — |
| Age, Continuous Phase 2 | — | — | 42.7 years STANDARD_DEVIATION 9.04 | 44 years STANDARD_DEVIATION 10 | 44 years STANDARD_DEVIATION 8 | 40 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Phase 1, Asian | 1 participants | 0 participants | 5 participants | — | — | — |
| Race/Ethnicity, Customized Phase 1, Black | 3 participants | 0 participants | 18 participants | — | — | — |
| Race/Ethnicity, Customized Phase 1, Hispanic | 5 participants | 2 participants | 19 participants | — | — | — |
| Race/Ethnicity, Customized Phase 1, Other | 0 participants | 0 participants | 1 participants | — | — | — |
| Race/Ethnicity, Customized Phase 1, White | 3 participants | 6 participants | 23 participants | — | — | — |
| Race/Ethnicity, Customized Phase 2, Asian | — | — | 4 participants | 0 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Phase 2, Black | — | — | 15 participants | 6 participants | 7 participants | 2 participants |
| Race/Ethnicity, Customized Phase 2, Hispanic | — | — | 12 participants | 4 participants | 4 participants | 4 participants |
| Race/Ethnicity, Customized Phase 2, Other | — | — | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Phase 2, White | — | — | 14 participants | 5 participants | 5 participants | 4 participants |
| Sex: Female, Male Phase 1 Female | 9 Participants | 5 Participants | 14 Participants | — | — | — |
| Sex: Female, Male Phase 1 Male | 3 Participants | 3 Participants | 6 Participants | — | — | — |
| Sex: Female, Male Phase 2 Female | — | — | 35 Participants | 11 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Phase 2 Male | — | — | 11 Participants | 4 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 4 | 2 / 2 | 1 / 4 | 2 / 4 | 1 / 4 | 1 / 2 | 2 / 15 | 2 / 16 | 3 / 15 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 2 | 0 / 15 | 0 / 16 | 0 / 15 |
Outcome results
Primary
Glucose, Urea and Creatinine Phase I
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug or placebo
Population: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Glucose, Urea and Creatinine Phase I | Glucose | 81 mg/dL | Standard Deviation 12 |
| Active Phase I Baseline | Glucose, Urea and Creatinine Phase I | Creatinine | 0.8 mg/dL | Standard Deviation 0.2 |
| Active Phase I Baseline | Glucose, Urea and Creatinine Phase I | Urea | 13 mg/dL | Standard Deviation 3 |
| Active Phase I Post Treatment | Glucose, Urea and Creatinine Phase I | Glucose | 79 mg/dL | Standard Deviation 9 |
| Active Phase I Post Treatment | Glucose, Urea and Creatinine Phase I | Creatinine | 0.8 mg/dL | Standard Deviation 0.2 |
| Active Phase I Post Treatment | Glucose, Urea and Creatinine Phase I | Urea | 13 mg/dL | Standard Deviation 3 |
| Placebo Phase I Baseline | Glucose, Urea and Creatinine Phase I | Urea | 16 mg/dL | Standard Deviation 4 |
| Placebo Phase I Baseline | Glucose, Urea and Creatinine Phase I | Glucose | 75 mg/dL | Standard Deviation 14 |
| Placebo Phase I Baseline | Glucose, Urea and Creatinine Phase I | Creatinine | 0.9 mg/dL | Standard Deviation 0.1 |
| Placebo Phase I Post Treatment | Glucose, Urea and Creatinine Phase I | Glucose | 71 mg/dL | Standard Deviation 7 |
| Placebo Phase I Post Treatment | Glucose, Urea and Creatinine Phase I | Creatinine | 0.9 mg/dL | Standard Deviation 0.2 |
| Placebo Phase I Post Treatment | Glucose, Urea and Creatinine Phase I | Urea | 17 mg/dL | Standard Deviation 5 |
Primary
Hemoglobin Laboratory Results in Phase I
Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1
Time frame: 1 week
Population: For the Phase I study descriptive statistics were used to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Phase I Baseline | Hemoglobin Laboratory Results in Phase I | 13 g/dL | Standard Deviation 0.9 |
| Active Phase I Post Treatment | Hemoglobin Laboratory Results in Phase I | 13 g/dL | Standard Deviation 1 |
| Placebo Phase I Baseline | Hemoglobin Laboratory Results in Phase I | 14 g/dL | Standard Deviation 2 |
| Placebo Phase I Post Treatment | Hemoglobin Laboratory Results in Phase I | 14 g/dL | Standard Deviation 1 |
Primary
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Population: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 76.0 IU/L | Standard Deviation 22.2 |
| Active Phase I Baseline | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 24.5 IU/L | Standard Deviation 8.4 |
| Active Phase I Baseline | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 23.9 IU/L | Standard Deviation 11.6 |
| Active Phase I Post Treatment | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 22.0 IU/L | Standard Deviation 9.3 |
| Active Phase I Post Treatment | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 21.9 IU/L | Standard Deviation 18.2 |
| Active Phase I Post Treatment | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 91.3 IU/L | Standard Deviation 23 |
| Placebo Phase I Baseline | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 21.3 IU/L | Standard Deviation 9.4 |
| Placebo Phase I Baseline | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 76.6 IU/L | Standard Deviation 24.7 |
| Placebo Phase I Baseline | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 24.7 IU/L | Standard Deviation 7.3 |
| Placebo Phase I Post Treatment | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 24.8 IU/L | Standard Deviation 8.1 |
| Placebo Phase I Post Treatment | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 81.1 IU/L | Standard Deviation 24.8 |
| Placebo Phase I Post Treatment | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 26.9 IU/L | Standard Deviation 11.9 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 22.0 IU/L | Standard Deviation 11 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 29.7 IU/L | Standard Deviation 25.7 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 25.8 IU/L | Standard Deviation 9.6 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 22.5 IU/L | Standard Deviation 8.6 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 83.2 IU/L | Standard Deviation 25 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 25.6 IU/L | Standard Deviation 8.7 |
| Placebo Phase II Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 25.3 IU/L | Standard Deviation 8.9 |
| Placebo Phase II Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 61.7 IU/L | Standard Deviation 18.5 |
| Placebo Phase II Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 24.3 IU/L | Standard Deviation 7.4 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 14.5 IU/L | Standard Deviation 4.9 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 21.0 IU/L | Standard Deviation 7.1 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 98.0 IU/L | Standard Deviation 5.7 |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic pyruvic transaminase (SGPT) | 32.0 IU/L | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Serum glutamic oxaloacetic transaminase (SGOT) | 30.0 IU/L | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study | Alkaline phosphatase | 78.0 IU/L | — |
Primary
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Population: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 29, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 14.8 mg/dL | Standard Deviation 4.1 |
| Active Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Active Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 85 mg/dL | Standard Deviation 28.4 |
| Active Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.4 mg/dL | Standard Deviation 0.2 |
| Active Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.9 mg/dL | Standard Deviation 0.2 |
| Active Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.8 mg/dL | Standard Deviation 0.2 |
| Active Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 79.1 mg/dL | Standard Deviation 12.1 |
| Active Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Active Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 13.3 mg/dL | Standard Deviation 5.4 |
| Active Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.4 mg/dL | Standard Deviation 0.2 |
| Placebo Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.4 mg/dL | Standard Deviation 0.2 |
| Placebo Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.8 mg/dL | Standard Deviation 0.1 |
| Placebo Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 77.1 mg/dL | Standard Deviation 12.8 |
| Placebo Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Placebo Phase I Baseline | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 14.1 mg/dL | Standard Deviation 5.4 |
| Placebo Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Placebo Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 13.9 mg/dL | Standard Deviation 2.6 |
| Placebo Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.5 mg/dL | Standard Deviation 0.2 |
| Placebo Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 99.9 mg/dL | Standard Deviation 45.9 |
| Placebo Phase I Post Treatment | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.8 mg/dL | Standard Deviation 0.1 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.9 mg/dL | Standard Deviation 0.3 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 77.6 mg/dL | Standard Deviation 8.8 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 13.3 mg/dL | Standard Deviation 2.5 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.4 mg/dL | Standard Deviation 0.2 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 14.2 mg/dL | Standard Deviation 4.2 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.9 mg/dL | Standard Deviation 0.2 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.3 mg/dL | Standard Deviation 0.1 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 72.5 mg/dL | Standard Deviation 12.6 |
| Placebo Phase II Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 1.0 mg/dL | Standard Deviation 0.1 |
| Placebo Phase II Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 15.0 mg/dL | Standard Deviation 2.6 |
| Placebo Phase II Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 92.0 mg/dL | Standard Deviation 12 |
| Placebo Phase II Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.4 mg/dL | Standard Deviation 0.2 |
| Placebo Phase II Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0.1 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.9 mg/dL | Standard Deviation 0.1 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 15.0 mg/dL | Standard Deviation 8.5 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | Standard Deviation 0 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.4 mg/dL | Standard Deviation 0.2 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 95.0 mg/dL | Standard Deviation 38.2 |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Direct | 0.1 mg/dL | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Glucose | 101.0 mg/dL | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Bilirubin Total | 0.2 mg/dL | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Urea | 18.0 mg/dL | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study | Creatinine | 0.3 mg/dL | — |
Primary
Laboratory Results for Hemoglobin in Subjects in Phase II Study
Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Population: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Phase I Baseline | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 13.5 g/dL | Standard Deviation 1.4 |
| Active Phase I Post Treatment | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 13.5 g/dL | Standard Deviation 1.6 |
| Placebo Phase I Baseline | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 12.8 g/dL | Standard Deviation 1.2 |
| Placebo Phase I Post Treatment | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 13.9 g/dL | Standard Deviation 1.2 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 13.7 g/dL | Standard Deviation 1.4 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 12.9 g/dL | Standard Deviation 1.5 |
| Placebo Phase II Visit 10 | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 13.7 g/dL | Standard Deviation 1.7 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 13.9 g/dL | Standard Deviation 1.5 |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Hemoglobin in Subjects in Phase II Study | 14.3 g/dL | — |
Primary
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Population: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 140.6 meq/L | Standard Deviation 1.6 |
| Active Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 3.9 meq/L | Standard Deviation 0.4 |
| Active Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.5 meq/L | Standard Deviation 2.2 |
| Active Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 27.2 meq/L | Standard Deviation 2.7 |
| Active Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 26.7 meq/L | Standard Deviation 2.5 |
| Active Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 140.3 meq/L | Standard Deviation 1.9 |
| Active Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.1 meq/L | Standard Deviation 0.2 |
| Active Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.6 meq/L | Standard Deviation 1.9 |
| Placebo Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.1 meq/L | Standard Deviation 0.3 |
| Placebo Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 27.5 meq/L | Standard Deviation 1.6 |
| Placebo Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.6 meq/L | Standard Deviation 2.5 |
| Placebo Phase I Baseline | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 140.5 meq/L | Standard Deviation 2.3 |
| Placebo Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 139.5 meq/L | Standard Deviation 2.1 |
| Placebo Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.1 meq/L | Standard Deviation 0.3 |
| Placebo Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.4 meq/L | Standard Deviation 2.2 |
| Placebo Phase I Post Treatment | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 25.8 meq/L | Standard Deviation 2.4 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.9 meq/L | Standard Deviation 3.2 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.1 meq/L | Standard Deviation 0.1 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 140.1 meq/L | Standard Deviation 2.2 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 26.2 meq/L | Standard Deviation 2 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 26.2 meq/L | Standard Deviation 1.7 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 139.6 meq/L | Standard Deviation 2.5 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.3 meq/L | Standard Deviation 3.5 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.1 meq/L | Standard Deviation 0.3 |
| Placebo Phase II Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 102.3 meq/L | Standard Deviation 0.6 |
| Placebo Phase II Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.2 meq/L | Standard Deviation 0.6 |
| Placebo Phase II Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 27.1 meq/L | Standard Deviation 1.6 |
| Placebo Phase II Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 139.7 meq/L | Standard Deviation 1.5 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 4.1 meq/L | Standard Deviation 0.5 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 26.3 meq/L | Standard Deviation 2.9 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 101.5 meq/L | Standard Deviation 2.1 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 140 meq/L | Standard Deviation 1.4 |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Sodium | 140.0 meq/L | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Bicarbonate | 19.2 meq/L | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Chloride | 108.0 meq/L | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study | Potassium | 3.8 meq/L | — |
Primary
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study
Summary of Laboratory data for White Blood Cell Count(cells\*10\^3/uL) and Platelet (cells\*10\^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Population: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009,the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 7.2 cells*10^3/uL | Standard Deviation 2.3 |
| Active Phase I Baseline | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 254.5 cells*10^3/uL | Standard Deviation 74.6 |
| Active Phase I Post Treatment | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 7.6 cells*10^3/uL | Standard Deviation 2.6 |
| Active Phase I Post Treatment | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 268.2 cells*10^3/uL | Standard Deviation 49 |
| Placebo Phase I Baseline | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 7.2 cells*10^3/uL | Standard Deviation 1.4 |
| Placebo Phase I Baseline | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 267.1 cells*10^3/uL | Standard Deviation 89.5 |
| Placebo Phase I Post Treatment | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 6.5 cells*10^3/uL | Standard Deviation 2.1 |
| Placebo Phase I Post Treatment | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 275.0 cells*10^3/uL | Standard Deviation 86.3 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 7.5 cells*10^3/uL | Standard Deviation 2.7 |
| Active Phase II (ASHMI 4 Caps) Visit 5 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 283.3 cells*10^3/uL | Standard Deviation 58.5 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 275.6 cells*10^3/uL | Standard Deviation 119.6 |
| Active Phase II (ASHMI 12 Caps) Visit 5 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 6.8 cells*10^3/uL | Standard Deviation 1.9 |
| Placebo Phase II Visit 10 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 280.0 cells*10^3/uL | Standard Deviation 133.8 |
| Placebo Phase II Visit 10 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 7.9 cells*10^3/uL | Standard Deviation 2.7 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 9.4 cells*10^3/uL | Standard Deviation 0.7 |
| Active Phase II (ASHMI 4 Caps) Visit 10 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 348.5 cells*10^3/uL | Standard Deviation 29 |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | White Blood Cell Count | 6.2 cells*10^3/uL | — |
| Active Phase II (ASHMI 12 Caps) Visit 10 | Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study | Platelet | 269.0 cells*10^3/uL | — |
Primary
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I
Summary of Laboratory data for White Blood Cell(cells\*10\^3/uL), Hemoglobin(cells\*10\^3/uL) and Platelet(cells\*10\^3/uL)in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug and placebo
Population: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | White Blood Cell | 7 cells*10^3/uL | Standard Deviation 2 |
| Active Phase I Baseline | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | Platelet | 292 cells*10^3/uL | Standard Deviation 81 |
| Active Phase I Post Treatment | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | Platelet | 238 cells*10^3/uL | Standard Deviation 123 |
| Active Phase I Post Treatment | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | White Blood Cell | 7 cells*10^3/uL | Standard Deviation 1 |
| Placebo Phase I Baseline | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | White Blood Cell | 7 cells*10^3/uL | Standard Deviation 2 |
| Placebo Phase I Baseline | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | Platelet | 281 cells*10^3/uL | Standard Deviation 60 |
| Placebo Phase I Post Treatment | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | White Blood Cell | 7 cells*10^3/uL | Standard Deviation 1 |
| Placebo Phase I Post Treatment | Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I | Platelet | 273 cells*10^3/uL | Standard Deviation 64 |
Primary
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I
Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug and placebo
Population: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic pyruvic transaminase (SGPT) | 19 IU/L | Standard Deviation 8 |
| Active Phase I Baseline | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic oxaloacetic transaminase (SGOT) | 20 IU/L | Standard Deviation 4 |
| Active Phase I Post Treatment | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic oxaloacetic transaminase (SGOT) | 20 IU/L | Standard Deviation 7 |
| Active Phase I Post Treatment | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic pyruvic transaminase (SGPT) | 20 IU/L | Standard Deviation 8 |
| Placebo Phase I Baseline | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic pyruvic transaminase (SGPT) | 21 IU/L | Standard Deviation 9 |
| Placebo Phase I Baseline | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic oxaloacetic transaminase (SGOT) | 24 IU/L | Standard Deviation 8 |
| Placebo Phase I Post Treatment | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic pyruvic transaminase (SGPT) | 20 IU/L | Standard Deviation 9 |
| Placebo Phase I Post Treatment | Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I | Serum glutamic oxaloacetic transaminase (SGOT) | 24 IU/L | Standard Deviation 10 |
Primary
Sodium, Potassium, Chloride and CO2 Phase I
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug or placebo
Population: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Sodium (meq/L) | 139 meq/L | Standard Deviation 2 |
| Active Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Potassium (meq/L) | 4 meq/L | Standard Deviation 0.3 |
| Active Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Chloride (meq/L) | 103 meq/L | Standard Deviation 2 |
| Active Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Carbon dioxide (meq/L) | 24 meq/L | Standard Deviation 3 |
| Active Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Potassium (meq/L) | 4 meq/L | Standard Deviation 0.4 |
| Active Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Chloride (meq/L) | 103 meq/L | Standard Deviation 1 |
| Active Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Carbon dioxide (meq/L) | 23 meq/L | Standard Deviation 2 |
| Active Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Sodium (meq/L) | 140 meq/L | Standard Deviation 2 |
| Placebo Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Chloride (meq/L) | 102 meq/L | Standard Deviation 1 |
| Placebo Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Potassium (meq/L) | 4 meq/L | Standard Deviation 0.4 |
| Placebo Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Carbon dioxide (meq/L) | 24 meq/L | Standard Deviation 2 |
| Placebo Phase I Baseline | Sodium, Potassium, Chloride and CO2 Phase I | Sodium (meq/L) | 139 meq/L | Standard Deviation 3 |
| Placebo Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Carbon dioxide (meq/L) | 24 meq/L | Standard Deviation 2 |
| Placebo Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Potassium (meq/L) | 4 meq/L | Standard Deviation 0.2 |
| Placebo Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Sodium (meq/L) | 139 meq/L | Standard Deviation 1 |
| Placebo Phase I Post Treatment | Sodium, Potassium, Chloride and CO2 Phase I | Chloride (meq/L) | 102 meq/L | Standard Deviation 2 |