PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial

November 15, 2014 updated by: Cui xuejun, Shanghai University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai,, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cohort 1
Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg)
Drug: Qishe 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
Experimental: cohort 2
Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg)
Drug: Qishe 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
Experimental: cohort 3
Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg)
Drug: Qishe 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma concentration of Qishe Pill
Time Frame: Dosing(0 hour)
5 ml blood samples for pharmacokinetic analysis
Dosing(0 hour)
Plasma concentration of Qishe Pill
Time Frame: 15 min after dosing
5 ml blood samples for pharmacokinetic analysis
15 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 30 min after dosing
5 ml blood samples for pharmacokinetic analysis
30 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 45 min after dosing
5 ml blood samples for pharmacokinetic analysis
45 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 60 min after dosing
5 ml blood samples for pharmacokinetic analysis
60 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 90 min after dosing
5 ml blood samples for pharmacokinetic analysis
90 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 120 min after dosing
5 ml blood samples for pharmacokinetic analysis
120 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 150 min after dosing
5 ml blood samples for pharmacokinetic analysis
150 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 180 min after dosing
5 ml blood samples for pharmacokinetic analysis
180 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 240 min after dosing
5 ml blood samples for pharmacokinetic analysis
240 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 360 min after dosing
5 ml blood samples for pharmacokinetic analysis
360 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 480 min after dosing
5 ml blood samples for pharmacokinetic analysis
480 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 600 min after dosing
5 ml blood samples for pharmacokinetic analysis
600 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 720 min after dosing
5 ml blood samples for pharmacokinetic analysis
720 min after dosing
Plasma concentrations of Qishe Pill
Time Frame: 1440 min after dosing
5 ml blood samples for pharmacokinetic analysis
1440 min after dosing
Plasma concentration of Qishe Pill
Time Frame: 2160 min after dosing
5 ml blood samples for pharmacokinetic analysis
2160 min after dosing
Plasma sampling of Qishe Pill for pharmacokinetic analysis
Time Frame: 2880 min after dosing
5 ml blood samples for pharmacokinetic analysis
2880 min after dosing
Vital signs
Time Frame: Dosing(0 hour)
body temperature, heart rate and blood pressure
Dosing(0 hour)
Vital signs
Time Frame: 180 min after dosing
body temperature, heart rate and blood pressure
180 min after dosing
Vital signs
Time Frame: 720 min after dosing
body temperature, heart rate and blood pressure
720 min after dosing
Vital signs
Time Frame: 1440 min after dosing
body temperature, heart rate and blood pressure
1440 min after dosing
Vital signs
Time Frame: 2160 min after dosing
body temperature, heart rate and blood pressure
2160 min after dosing
Vital signs
Time Frame: 2880 min after dosing
body temperature, heart rate and blood pressure
2880 min after dosing
ECG monitoring
Time Frame: Dosing(0 hour)
Electrocardiograms (ECGs)
Dosing(0 hour)
ECG monitoring
Time Frame: 180 min after dosing
Electrocardiograms (ECGs)
180 min after dosing
ECG monitoring
Time Frame: 720 min after dosing
Electrocardiograms (ECGs)
720 min after dosing
ECG monitoring
Time Frame: 1440 min after dosing
Electrocardiograms (ECGs)
1440 min after dosing
ECG monitoring
Time Frame: 2160 min after dosing
Electrocardiograms (ECGs)
2160 min after dosing
ECG monitoring
Time Frame: 2880 min after dosing
Electrocardiograms (ECGs)
2880 min after dosing
Number of Participants with Adverse Events
Time Frame: 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.
Day 1 of drug administration and blood sampling
Number of Participants with Adverse Events
Time Frame: Day 2 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.
Day 2 of drug administration and blood sampling
Number of Participants with Adverse Events
Time Frame: Day 3 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.
Day 3 of drug administration and blood sampling
Number of Participants with Adverse Events
Time Frame: 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.
4 days after drug administration and blood sampling
Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage
Time Frame: 4 days after drug administration and blood sampling
The maximum plasma concentration
4 days after drug administration and blood sampling
Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage
Time Frame: 4 days after drug administration and blood sampling
The maximum plasma concentration
4 days after drug administration and blood sampling
Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage
Time Frame: 4 days after drug administration and blood sampling
The maximum plasma concentration
4 days after drug administration and blood sampling
The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in low dosage
Time Frame: 4 days after drug administration and blood sampling
The time to maximum concentration
4 days after drug administration and blood sampling
The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in medial dosage
Time Frame: 4 days after drug administration and blood sampling
The time to maximum concentration
4 days after drug administration and blood sampling
The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in high dosage
Time Frame: 4 days after drug administration and blood sampling
The time to maximum concentration
4 days after drug administration and blood sampling
Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in low dosage
Time Frame: 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.
4 days after drug administration and blood sampling
Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in medial dosage
Time Frame: 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.
4 days after drug administration and blood sampling
Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in high dosage
Time Frame: 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.
4 days after drug administration and blood sampling
The distribution volume (DF) of Qishe Pill in low dosage
Time Frame: 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.
4 days after drug administration and blood sampling
The distribution volume (DF) of Qishe Pill in medial dosage
Time Frame: 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.
4 days after drug administration and blood sampling
The distribution volume (DF) of Qishe Pill in high dosage
Time Frame: 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.
4 days after drug administration and blood sampling

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Deep phenotyping with genomics and functional genomics approaches
Time Frame: 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.
Dosing(0 hour)
Deep phenotyping with genomics and functional genomics approaches
Time Frame: 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.
2880 min after dosing

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Constitution in Chinese Medicine Questionnaire (CCMQ)
Time Frame: During screening in the recuitment
Two qualified traditional Chinese medical doctors licensed by the Chinese government determine the constitution according to CCMQ
During screening in the recuitment
The Constitution in Chinese Medicine Questionnaire (CCMQ)
Time Frame: 2880 min after dosing
Two qualified traditional Chinese medical doctors licensed by the Chinese government determine the constitution according to CCMQ
2880 min after dosing
Laboratory measures and clinical assessment
Time Frame: 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.
During screening in the recuitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PopPK profile of Qishe Pill

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