Population Pharmacokinetic Modeling of Qishe Pill in Three Major TCM-defined Constitutional Types of Healthy Chinese Subjects: Study Protocol for a Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Plasma concentration of Qishe Pill
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cohort 1
Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg)
干预措施: Qishe Pill (Drug)
cohort 2
Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg)
干预措施: Qishe Pill (Drug)
cohort 3
Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg)
干预措施: Qishe Pill (Drug)
结局指标
主要结局
Plasma concentration of Qishe Pill
时间窗: 2160 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentrations of Qishe Pill
时间窗: 1440 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma sampling of Qishe Pill for pharmacokinetic analysis
时间窗: 2880 min after dosing
5 ml blood samples for pharmacokinetic analysis
Vital signs
时间窗: 2880 min after dosing
body temperature, heart rate and blood pressure
ECG monitoring
时间窗: 2880 min after dosing
Electrocardiograms (ECGs)
Number of Participants with Adverse Events
时间窗: 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
时间窗: 4 days after drug administration and blood sampling
The maximum plasma concentration
Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage
时间窗: 4 days after drug administration and blood sampling
The maximum plasma concentration
Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Deep phenotyping with genomics and functional genomics approaches(2880 min after dosing)
研究者
Cui xuejun
Vice director
Shanghai University of Traditional Chinese Medicine