Individuality, Narrative Medicine
Conditions
Keywords
Cervical radiculopathy, Neck pain, Qishe pill, raditional Chinese medicine, healthy Chinese subject, Population Pharmacokinetics, Personalized Medicine, Individualized Medicine
Brief summary
Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China), composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus, has been developed and spread in use into clinical settings in 2009. As individualization has become the trend of modern medicine, a personalized medicine of Qishe Pill should be documented and practiced with various patients according to the ancient TCM system, a classification of personalized constitution type, which has been established to determine predisposition and prognosis to diseases as well as therapy and life-style administration. Therefore, we describe the population pharmacokinetic profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of individualized and standardized Traditional Chinese Medicine into clinical practice.
Detailed description
With the greatly increased morbidity of neck pain, it brought a large challenge to some optimal therapies for various situations in population at a given time based on their demographic, physiological and pathological characteristics. Chinese proprietary herbal medicines, as a kind of Complementary and Alternative Medicine (CAM), are usually developed from some well-established and long-standing recipes and formulated as tablets or capsules for commerce, convenience or palatability. Although these advantage mentioned, a good quantification and a strict standardization in detail are still need to be improved for individualized implementation in therapeutic strategies. Based on the YQHY decoction (Yi-Qi Hua-Yu Decoction, tonify Qi and promoting circulation and removing stasis), Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) has been developed and spread in use into clinical settings in 2009. As individualization has become the trend of modern medicine, a personalized medicine of Qishe Pill should be documented and practiced with various patients according to the ancient TCM system, a classification of personalized constitution type, which has been established to determine predisposition and prognosis to diseases as well as therapy and life-style administration. Therefore, we describe the population pharmacokinetic profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of individualized and standardized Traditional Chinese Medicine into clinical practice.
Interventions
DRUGQishe Pill
Qishe Pill is a thin 0.15 g film-coated pill, composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus, which should be taken orally with water (240mL) after a minimum 10-hour fast
Sponsors
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion * Aged 20-35 * 18.5 kg/m2 ≤Body mass index (BMI) \<23 kg/m2 * TCM-constitutionally typed as either the 3 major type Exclusion * History of impaired fasting glucose or diabetes mellitus (past history of diabetes or fasting blood glucose at screening ≥100 mg/dl) * History of liver disease (hepatitis, hepatic cirrhosis) or hepatic dysfunction (AST or ALT at screening ≥40 U/L) * History of renal dysfunction (creatinine at screening ≥1.2 mg/dl) * History of heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia) * History of malignant tumor * Having digestive disorders that can interfere with normal absorption of standard diet (gastritis, gastric ulcer, duodenitis, duodenal ulcer, etc.) * Smoking during the recent 3 months * Alcohol consumption 3 or more times a week during the recent 3 months * Women who were pregnant, intended to become pregnant, or breast- feeding * Medicated during the recent month for therapeutic or prophylactic purposes * Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The distribution volume (DF) of Qishe Pill in high dosage | 4 days after drug administration and blood sampling | The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant. |
| Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in high dosage | 4 days after drug administration and blood sampling | The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule. |
| The distribution volume (DF) of Qishe Pill in low dosage | 4 days after drug administration and blood sampling | The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant. |
| The distribution volume (DF) of Qishe Pill in medial dosage | 4 days after drug administration and blood sampling | The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant. |
| Plasma concentration of Qishe Pill | Dosing(0 hour) | 5 ml blood samples for pharmacokinetic analysis |
| Plasma concentrations of Qishe Pill | 1440 min after dosing | 5 ml blood samples for pharmacokinetic analysis |
| Plasma sampling of Qishe Pill for pharmacokinetic analysis | 2880 min after dosing | 5 ml blood samples for pharmacokinetic analysis |
| Vital signs | Dosing(0 hour) | body temperature, heart rate and blood pressure |
| ECG monitoring | Dosing(0 hour) | Electrocardiograms (ECGs) |
| Number of Participants with Adverse Events | Day 1 of drug administration and blood sampling | The investigators will assess all clinical AEs according to the Medical Dictionary for Regular Activities criteria, in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study drug. |
| Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage | 4 days after drug administration and blood sampling | The maximum plasma concentration |
| Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage | 4 days after drug administration and blood sampling | The maximum plasma concentration |
| Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage | 4 days after drug administration and blood sampling | The maximum plasma concentration |
| The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in low dosage | 4 days after drug administration and blood sampling | The time to maximum concentration |
| The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in medial dosage | 4 days after drug administration and blood sampling | The time to maximum concentration |
| The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in high dosage | 4 days after drug administration and blood sampling | The time to maximum concentration |
| Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in low dosage | 4 days after drug administration and blood sampling | The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule. |
| Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in medial dosage | 4 days after drug administration and blood sampling | The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deep phenotyping with genomics and functional genomics approaches | Dosing(0 hour) | 3 ml blood samples for genomic variants analysis. The cytochrome P450 gene family, such as CYP1A1, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP3A4 and CYP3A5 , etc, will be chosen as the target objective. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Laboratory measures and clinical assessment | During screening in the recuitment | These parameters including blood count, electrolytes, renal and liver function parameters, blood lipids, age, gender, history of smoking, blood pressure, weight (kg), and height (meters) will be obtained for all subjects. |
| The Constitution in Chinese Medicine Questionnaire (CCMQ) | During screening in the recuitment | Two qualified traditional Chinese medical doctors licensed by the Chinese government determine the constitution according to CCMQ |
Countries
China
Contacts
Primary ContactXue-Jun Cui, Dr.
Backup ContactYue-li Sun, Dr
Outcome results
None listed