Benign Prostatic Hyperplasia
Conditions
Brief summary
To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze twice daily administration for 56 days in patients with BPH.
Detailed description
The study product, Umooze, contain Astragalus radix extracts and Soy extracts as the combination of 960:40 in one 500 mg tablet. Umooze is sold in the market as food. The objective of this study is to evaluate the benefit of Umooze as add- on therapy in BPH, by evaluation the improvement in symptoms of BPH assessed according to the International Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze in patients with BPH. The IPSS is a validated 7-item urinary symptom severity scale. A randomized, two-regimen, placebo-controlled, parallel- design is used in this study in which each subject will receive Umooze or placebo. The add- on study product will be administered twice daily for 56 days. Benefit will be evaluated at baseline and subsequently on the study day 28, 42, and 56, such as IPSS index, QoL index, Qmax, PVR, prostate volume and Prostate-specific antigen(PSA).
Interventions
DIETARY_SUPPLEMENTUmooze
Umooze is consisted of Astragalus radix extracts and soy extracts. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia.
DIETARY_SUPPLEMENTPlacebo
Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.
Sponsors
Golden Biotechnology Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males aged \>=40 years old * Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS) * Prostate volume \>= 20 cm3 * Has complained of voiding symptoms related to BPH * Has an IPSS \>= 13 or an UFR measure of Qmax \<= 15 ml/sec together with a voided volume \>= 150 ml. * Serum PSA \< 6.5 ng/ml * Has been treated with medication for BPH * Informed consent form signed.
Exclusion criteria
* Sensitivity to study product * Had received prostatic surgery for BPH during the past 24 weeks * Hard nodule found by DRE * Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease. * Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator. * Participation of any clinical investigation during the last 30 days. * Individuals are judged by the investigators or co- investigator to be undesirable as subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge | 56 days | The Quality of Life (QoL) is a single question with scores of 0\ 6 point and corresponding to the assessment index ranging from delighted to terrible. |
| International Prostate Symptom Score (IPSS) | 56 days | It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points. |
| Quality- Of- Life Index (QoL) | 56 days | The QoL index is a single question with scores of 0\ 6 point and corresponding to the assessment index ranging from delighted to terrible. |
| International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months | 56 days | It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Flow Rate (Qmax) | 56 days | It's used to determine the degree of urinary difficulty. |
| Postvoid Residual Volume (PVR) | 56 days | The PVR urine test measures the amount of urine left in the bladder after urination. |
| Prostate Volume | 56 days | It's related to progression of benign prostatic hyperplasia (BPH). |
| Prostate-specific Antigen (PSA) Level | 56 days | Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Umooze Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg
Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water. | 18 |
| Placebo Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water. | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative reason | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | Umooze |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 10 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 8 Participants | 11 Participants |
| Different original medications and dosages Doxaben® 4 mg QD treatment | 4 participants | 2 participants | 2 participants |
| Different original medications and dosages Doxaben® XL 4 mg QD treatment | 4 participants | 2 participants | 2 participants |
| Different original medications and dosages Harnalidge® 0.1 mg QD treatment | 1 participants | 0 participants | 1 participants |
| Different original medications and dosages Harnalidge® 0.2 mg QD treatment | 5 participants | 3 participants | 2 participants |
| Different original medications and dosages Harnalidge® 0.4 mg QD treatment | 22 participants | 11 participants | 11 participants |
| Internation Prostate Symptom Score (IPSS) | 16.36 units on a scale STANDARD_DEVIATION 7.67 | 19.5 units on a scale STANDARD_DEVIATION 8.03 | 13.22 units on a scale STANDARD_DEVIATION 6.26 |
| Postvoid Residual Volume (PVR) | 48.06 ml STANDARD_DEVIATION 50 | 52.4 ml STANDARD_DEVIATION 67 | 43.7 ml STANDARD_DEVIATION 27.6 |
| Prostate volume | 39.10 cm^3 STANDARD_DEVIATION 18.51 | 39.5 cm^3 STANDARD_DEVIATION 16.9 | 37.2 cm^3 STANDARD_DEVIATION 20.1 |
| Quality-of-Life | 3.56 units on a scale STANDARD_DEVIATION 1.34 | 3.78 units on a scale STANDARD_DEVIATION 1.22 | 3.33 units on a scale STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 36 Participants | 18 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 36 participants | 18 participants | 18 participants |
| Serum Total Prostate-Specific Antigen level (PSA) | 1.74 nanograms/ ml STANDARD_DEVIATION 1.31 | 1.95 nanograms/ ml STANDARD_DEVIATION 1.31 | 1.54 nanograms/ ml STANDARD_DEVIATION 1.34 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 36 Participants | 18 Participants | 18 Participants |
| Uroflowmetry (UFR) measure of maximum flow rate (Qmax) | 10.85 ml/ sec STANDARD_DEVIATION 3.29 | 10.23 ml/ sec STANDARD_DEVIATION 3.71 | 11.5 ml/ sec STANDARD_DEVIATION 2.88 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 20 | 2 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
International Prostate Symptom Score (IPSS)
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Time frame: 56 days
Population: For all subjects' medical histories in this study, there are one subject receiving Hatnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | International Prostate Symptom Score (IPSS) | International prostate symptom score | 9.83 units on a scale | Standard Deviation 4.48 |
| Umooze | International Prostate Symptom Score (IPSS) | Difference in IPSS between V1 and V6 | -3.39 units on a scale | Standard Deviation 6.11 |
| Placebo | International Prostate Symptom Score (IPSS) | International prostate symptom score | 13.6 units on a scale | Standard Deviation 6.88 |
| Placebo | International Prostate Symptom Score (IPSS) | Difference in IPSS between V1 and V6 | -5.94 units on a scale | Standard Deviation 8.11 |
Primary
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Time frame: 56 days
Population: All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months | International prostate symptom score | 11.00 units on a scale | Standard Deviation 4.24 |
| Umooze | International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months | Difference in IPSS between V1 and V6 | -9.50 units on a scale | Standard Deviation 3.54 |
| Placebo | International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months | International prostate symptom score | 14.33 units on a scale | Standard Deviation 3.21 |
| Placebo | International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months | Difference in IPSS between V1 and V6 | -4.33 units on a scale | Standard Deviation 1.53 |
p-value: <0.05t-test, 1 sided
Primary
Quality- Of- Life Index (QoL)
The QoL index is a single question with scores of 0\ 6 point and corresponding to the assessment index ranging from delighted to terrible.
Time frame: 56 days
Population: For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Hatnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | Quality- Of- Life Index (QoL) | Quality-of-Life (QoL) | 2.72 units on a scale | Standard Deviation 1.07 |
| Umooze | Quality- Of- Life Index (QoL) | Difference of QoL between V1 and V6 | -0.61 units on a scale | Standard Deviation 1.2 |
| Placebo | Quality- Of- Life Index (QoL) | Quality-of-Life (QoL) | 3.22 units on a scale | Standard Deviation 1.17 |
| Placebo | Quality- Of- Life Index (QoL) | Difference of QoL between V1 and V6 | -0.56 units on a scale | Standard Deviation 1.2 |
Primary
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
The Quality of Life (QoL) is a single question with scores of 0\ 6 point and corresponding to the assessment index ranging from delighted to terrible.
Time frame: 56 days
Population: All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge | Quality of Life (QoL) | 2.73 units on a scale | Standard Deviation 1.1 |
| Umooze | Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge | Difference of QoL between V1 and V6 | -0.82 units on a scale | Standard Deviation 0.87 |
| Placebo | Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge | Quality of Life (QoL) | 3.27 units on a scale | Standard Deviation 1.1 |
| Placebo | Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge | Difference of QoL between V1 and V6 | -0.09 units on a scale | Standard Deviation 0.7 |
p-value: <0.05t-test, 1 sided
Secondary
Maximum Flow Rate (Qmax)
It's used to determine the degree of urinary difficulty.
Time frame: 56 days
Population: For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | Maximum Flow Rate (Qmax) | Qmax | 14.4 ml/ sec | Standard Deviation 4.29 |
| Umooze | Maximum Flow Rate (Qmax) | Difference of Qmax between V1 and V6 | 2.88 ml/ sec | Standard Deviation 3.77 |
| Placebo | Maximum Flow Rate (Qmax) | Qmax | 12.72 ml/ sec | Standard Deviation 6.57 |
| Placebo | Maximum Flow Rate (Qmax) | Difference of Qmax between V1 and V6 | 2.49 ml/ sec | Standard Deviation 5.46 |
Secondary
Postvoid Residual Volume (PVR)
The PVR urine test measures the amount of urine left in the bladder after urination.
Time frame: 56 days
Population: For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receivingHarnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | Postvoid Residual Volume (PVR) | Post- Void Residual Volume (PVR) | 35.3 ml | Standard Deviation 35.9 |
| Umooze | Postvoid Residual Volume (PVR) | Difference of PVR between V1 and V6 | -8.39 ml | Standard Deviation 31.9 |
| Placebo | Postvoid Residual Volume (PVR) | Post- Void Residual Volume (PVR) | 67.2 ml | Standard Deviation 47.8 |
| Placebo | Postvoid Residual Volume (PVR) | Difference of PVR between V1 and V6 | 14.8 ml | Standard Deviation 32.8 |
p-value: <0.05t-test, 1 sided
Secondary
Prostate-specific Antigen (PSA) Level
Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.
Time frame: 56 days
Population: For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | Prostate-specific Antigen (PSA) Level | Prostate- specific Antigen (PSA) | 1.67 ng/ml | Standard Deviation 1.34 |
| Umooze | Prostate-specific Antigen (PSA) Level | Difference of PSA between V1 and V6 | 0.14 ng/ml | Standard Deviation 0.32 |
| Placebo | Prostate-specific Antigen (PSA) Level | Prostate- specific Antigen (PSA) | 2.22 ng/ml | Standard Deviation 1.69 |
| Placebo | Prostate-specific Antigen (PSA) Level | Difference of PSA between V1 and V6 | 0.26 ng/ml | Standard Deviation 0.76 |
Secondary
Prostate Volume
It's related to progression of benign prostatic hyperplasia (BPH).
Time frame: 56 days
Population: For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umooze | Prostate Volume | Prostate Volume | 29.1 cm^3 | Standard Deviation 11.5 |
| Umooze | Prostate Volume | Difference of prostate volume between V1 and V6 | -8.17 cm^3 | Standard Deviation 12.7 |
| Placebo | Prostate Volume | Prostate Volume | 38.2 cm^3 | Standard Deviation 20.1 |
| Placebo | Prostate Volume | Difference of prostate volume between V1 and V6 | -1.33 cm^3 | Standard Deviation 7.36 |
p-value: <0.05t-test, 1 sided