PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial
- Conditions
- IndividualityNarrative Medicine
- Interventions
- Drug: Qishe Pill
- Registration Number
- NCT02294448
- Lead Sponsor
- Shanghai University of Traditional Chinese 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cohort 2 Qishe Pill Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg) cohort 3 Qishe Pill Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg) cohort 1 Qishe Pill Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg)
- Primary Outcome Measures
Name Time Method Plasma concentration of Qishe Pill 2160 min after dosing 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 2880 min after dosing body temperature, heart rate and blood pressure
ECG monitoring 2880 min after dosing Electrocardiograms (ECGs)
Number of Participants with Adverse Events 4 days after drug administration and blood sampling Subjects will be requested to return to the study unit 4 d after drug administration and blood sampling for a follow-up visit.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method Deep phenotyping with genomics and functional genomics approaches 2880 min after dosing 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.
Trial Locations
- Locations (1)
Longhua Hospital, Shanghai University of TCM
🇨🇳Shanghai,, Shanghai, China