Clinical trial NCT02294448: PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Individuality
Narrative Medicine
Keywords: Cervical radiculopathy
Neck pain
Qishe pill
raditional Chinese medicine
healthy Chinese subject
Population Pharmacokinetics
Personalized Medicine
Individualized Medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Plasma concentration of Qishe Pill
timeFrame: Dosing(0 hour)
measure: Plasma concentration of Qishe Pill
timeFrame: 15 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 30 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 45 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 60 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 90 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 120 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 150 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 180 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 240 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 360 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 480 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 600 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 720 min after dosing
measure: Plasma concentrations of Qishe Pill
timeFrame: 1440 min after dosing
measure: Plasma concentration of Qishe Pill
timeFrame: 2160 min after dosing
measure: Plasma sampling of Qishe Pill for pharmacokinetic analysis
timeFrame: 2880 min after dosing
measure: Vital signs
timeFrame: Dosing(0 hour)
measure: Vital signs
timeFrame: 180 min after dosing
measure: Vital signs
timeFrame: 720 min after dosing
measure: Vital signs
timeFrame: 1440 min after dosing
measure: Vital signs
timeFrame: 2160 min after dosing
measure: Vital signs
timeFrame: 2880 min after dosing
measure: ECG monitoring
timeFrame: Dosing(0 hour)
measure: ECG monitoring
timeFrame: 180 min after dosing
measure: ECG monitoring
timeFrame: 720 min after dosing
measure: ECG monitoring
timeFrame: 1440 min after dosing
measure: ECG monitoring
timeFrame: 2160 min after dosing
measure: ECG monitoring
timeFrame: 2880 min after dosing
measure: Number of Participants with Adverse Events
timeFrame: Day 1 of drug administration and blood sampling
measure: Number of Participants with Adverse Events
timeFrame: Day 2 of drug administration and blood sampling
measure: Number of Participants with Adverse Events
timeFrame: Day 3 of drug administration and blood sampling
measure: Number of Participants with Adverse Events
timeFrame: 4 days after drug administration and blood sampling
measure: Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage
timeFrame: 4 days after drug administration and blood sampling
measure: Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage
timeFrame: 4 days after drug administration and blood sampling
measure: Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage
timeFrame: 4 days after drug administration and blood sampling
measure: The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in low dosage
timeFrame: 4 days after drug administration and blood sampling
measure: The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in medial dosage
timeFrame: 4 days after drug administration and blood sampling
measure: The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in high dosage
timeFrame: 4 days after drug administration and blood sampling
measure: Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in low dosage
timeFrame: 4 days after drug administration and blood sampling
measure: Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in medial dosage
timeFrame: 4 days after drug administration and blood sampling
measure: Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in high dosage
timeFrame: 4 days after drug administration and blood sampling
measure: The distribution volume (DF) of Qishe Pill in low dosage
timeFrame: 4 days after drug administration and blood sampling
measure: The distribution volume (DF) of Qishe Pill in medial dosage
timeFrame: 4 days after drug administration and blood sampling
measure: The distribution volume (DF) of Qishe Pill in high dosage
timeFrame: 4 days after drug administration and blood sampling
Secondary outcomes:
measure: Deep phenotyping with genomics and functional genomics approaches
timeFrame: Dosing(0 hour)
measure: Deep phenotyping with genomics and functional genomics approaches
timeFrame: 2880 min after dosing
Other outcomes:
measure: The Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: During screening in the recuitment
measure: The Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: 2880 min after dosing
measure: Laboratory measures and clinical assessment
timeFrame: During screening in the recuitment
Locations:
city: Shanghai,
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
Study officials:
affiliation: Longhua Hospital
name: Yong-jun Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
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