IndividualityPhase 1NCT02294448
PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial
A Phase 1 study testing Qishe Pill in people with Individuality and Narrative Medicine, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuality, Narrative Medicine
- What is being tested?
- Qishe Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-35
- 18.5 kg/m2 ≤Body mass index (BMI) <23 kg/m2
- TCM-constitutionally typed as either the 3 major type
Who cannot join
- 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.)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Xue-Jun Cui, Dr. contact
Yue-li Sun, Dr contact
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Yue-li Sun, Dr, edisonlike2008@gmail.com
Ting Hou, Miss, Houting003@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Individuality, Narrative Medicine
- Being tested
- Qishe Pill
- Keywords
- Cervical radiculopathy, Neck pain, Qishe pill, raditional Chinese medicine, healthy Chinese subject, Population Pharmacokinetics, Personalized Medicine, Individualized Medicine
- Medical subject headings
- Narrative Medicine, Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishe PillDrug
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
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg) Receives: Drug: Qishe Pill |
| cohort 2 | Experimental | Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg) Receives: Drug: Qishe Pill |
| cohort 3 | Experimental | Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg) Receives: Drug: Qishe Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: Dosing(0 hour)
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 15 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 30 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 45 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 60 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 90 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 120 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 150 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 180 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 240 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 360 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 480 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 600 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 720 min after dosing
Plasma concentrations of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 1440 min after dosing
Plasma concentration of Qishe Pill
5 ml blood samples for pharmacokinetic analysis
Measured: 2160 min after dosing
Plasma sampling of Qishe Pill for pharmacokinetic analysis
5 ml blood samples for pharmacokinetic analysis
Measured: 2880 min after dosing
Vital signs
body temperature, heart rate and blood pressure
Measured: Dosing(0 hour)
Vital signs
body temperature, heart rate and blood pressure
Measured: 180 min after dosing
Vital signs
body temperature, heart rate and blood pressure
Measured: 720 min after dosing
Vital signs
body temperature, heart rate and blood pressure
Measured: 1440 min after dosing
Vital signs
body temperature, heart rate and blood pressure
Measured: 2160 min after dosing
Vital signs
body temperature, heart rate and blood pressure
Measured: 2880 min after dosing
ECG monitoring
Electrocardiograms (ECGs)
Measured: Dosing(0 hour)
ECG monitoring
Electrocardiograms (ECGs)
Measured: 180 min after dosing
ECG monitoring
Electrocardiograms (ECGs)
Measured: 720 min after dosing
ECG monitoring
Electrocardiograms (ECGs)
Measured: 1440 min after dosing
ECG monitoring
Electrocardiograms (ECGs)
Measured: 2160 min after dosing
ECG monitoring
Electrocardiograms (ECGs)
Measured: 2880 min after dosing
Number of Participants with Adverse Events
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.
Measured: Day 1 of drug administration and blood sampling
Number of Participants with Adverse Events
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.
Measured: Day 2 of drug administration and blood sampling
Number of Participants with Adverse Events
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.
Measured: Day 3 of drug administration and blood sampling
Number of Participants with Adverse Events
Subjects will be requested to return to the study unit 4 d after drug administration and blood sampling for a follow-up visit.
Measured: 4 days after drug administration and blood sampling
Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage
The maximum plasma concentration
Measured: 4 days after drug administration and blood sampling
Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage
The maximum plasma concentration
Measured: 4 days after drug administration and blood sampling
Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage
The maximum plasma concentration
Measured: 4 days after drug administration and blood sampling
The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in low dosage
The time to maximum concentration
Measured: 4 days after drug administration and blood sampling
The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in medial dosage
The time to maximum concentration
Measured: 4 days after drug administration and blood sampling
The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in high dosage
The time to maximum concentration
Measured: 4 days after drug administration and blood sampling
Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in low dosage
The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.
Measured: 4 days after drug administration and blood sampling
Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in medial dosage
The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.
Measured: 4 days after drug administration and blood sampling
Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in high dosage
The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.
Measured: 4 days after drug administration and blood sampling
The distribution volume (DF) of Qishe Pill in low dosage
The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.
Measured: 4 days after drug administration and blood sampling
The distribution volume (DF) of Qishe Pill in medial dosage
The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.
Measured: 4 days after drug administration and blood sampling
The distribution volume (DF) of Qishe Pill in high dosage
The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.
Measured: 4 days after drug administration and blood sampling
Secondary outcomes (2)
Deep phenotyping with genomics and functional genomics approaches
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.
Measured: Dosing(0 hour)
Deep phenotyping with genomics and functional genomics approaches
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.
Measured: 2880 min after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for IndividualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yong-jun Wang, Dr., Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294448
- Sponsor's protocol ID
- PopPK profile of Qishe Pill
- Status last verified
- Nov 2014
- First submitted
- 11 Sep 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aker PD, Gross AR, Goldsmith CH, Peloso P. Conservative management of mechanical neck pain: systematic overview and meta-analysis. BMJ. 1996 Nov 23;313(7068):1291-6.
PubMed 8942688Cui X, Trinh K, Wang YJ. Chinese herbal medicine for chronic neck pain due to cervical degenerative disc disease. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006556. doi: 10.1002/14651858.CD006556.pub2.
PubMed 20091597Wang Q. Classification of the nine basic TCM constitutional type and based expression and diagnosis. Journal of Beijing University of Traditional Chinese medicine. 2005.1-8
Liu Mei, Zhang N, Wang YJ, Shi Q. Purification process research of major compound in Qishe Pill as Astragalus. Acta Chinese Medicine and Pharmacology. 2006(34):14-16.
Zhang YQ, Liu XH, Zhang N, Liu M. Quality standard research of Qishe Pill. Lishizhen Med Mater Med Res. 2008(19): 977-979.
Liu M, Zhang N, Wang YJ, Zhang YQ, Zhou CJ. Technology research of Qishe Pill, a new medicine for cervical spondylosis. Lishizhen Med Mater Med Res. 2010(21):176-179.
Ge JR, Wang HM, Meng CX, Tong PJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: a randomized controlled trial for Phase III. Chinese Journal of New Drugs and Clinical. 2014(7):56-58.
Johnson CL, Fulwood R, Abraham S, Bryner JD. Basic data on anthropometric measurements and angular measurements of the hip and knee joints for selected age groups 1-74 years of age. Vital Health Stat 11. 1981 Apr;(219):1-68. No abstract available.
PubMed 15806754Makela M, Heliovaara M, Sievers K, Impivaara O, Knekt P, Aromaa A. Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol. 1991 Dec 1;134(11):1356-67. doi: 10.1093/oxfordjournals.aje.a116038.
PubMed 1755449Bovim G, Schrader H, Sand T. Neck pain in the general population. Spine (Phila Pa 1976). 1994 Jun 15;19(12):1307-9. doi: 10.1097/00007632-199406000-00001.
PubMed 8066508van der Donk J, Schouten JS, Passchier J, van Romunde LK, Valkenburg HA. The associations of neck pain with radiological abnormalities of the cervical spine and personality traits in a general population. J Rheumatol. 1991 Dec;18(12):1884-9.
PubMed 1795327Hsu H-Y: 1986 Oriental MateriaMedica. Long Beach, CA: Oriental Healing Arts Institute; 1986.
Zhu YB, Wang Q, Xue HS, Origasa H. Preliminary assessment on performance of constitution in Chinese medicine questionnaire. ZhongGuo Lin Chuang Kang Fu 2006; 10 (3): 15-17.
FDA/CDER. Guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers; 2005, http://www.fda.gov/downloads/drugs/guidance-complianceregulatoryinformation/guidances/ucm078932.pdf.
EMEA. Strategies to identify and mitigate risks for first-in-human clinical trialswith investigational medicinal products; 2009, http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500002988.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02294448
- Acronym / sponsor ID
- PopPK profile of Qishe Pill
- Conditions
- Individuality, Narrative Medicine
- Keywords
- Cervical radiculopathy, Neck pain, Qishe pill, raditional Chinese medicine, healthy Chinese subject, Population Pharmacokinetics, Personalized Medicine, Individualized Medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: Qishe PillQishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg) |
| cohort 2 | Experimental | Drug: Qishe PillQishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg) |
| cohort 3 | Experimental | Drug: Qishe PillQishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 20-35
- 18.5 kg/m2 ≤Body mass index (BMI) <23 kg/m2
- TCM-constitutionally typed as either the 3 major type
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qishe PillQishe 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 | Drug | cohort 1, cohort 2, cohort 3 |
Primary outcome
Plasma concentration of Qishe Pill
Time frame: Dosing(0 hour)
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 15 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 30 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 45 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 60 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 90 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 120 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 150 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 180 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 240 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 360 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 480 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 600 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 720 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentrations of Qishe Pill
Time frame: 1440 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma concentration of Qishe Pill
Time frame: 2160 min after dosing
5 ml blood samples for pharmacokinetic analysis
Plasma sampling of Qishe Pill for pharmacokinetic analysis
Time frame: 2880 min after dosing
5 ml blood samples for pharmacokinetic analysis
Vital signs
Time frame: Dosing(0 hour)
body temperature, heart rate and blood pressure
Vital signs
Time frame: 180 min after dosing
body temperature, heart rate and blood pressure
Vital signs
Time frame: 720 min after dosing
body temperature, heart rate and blood pressure
Vital signs
Time frame: 1440 min after dosing
body temperature, heart rate and blood pressure
Vital signs
Time frame: 2160 min after dosing
body temperature, heart rate and blood pressure
Vital signs
Time frame: 2880 min after dosing
body temperature, heart rate and blood pressure
ECG monitoring
Time frame: Dosing(0 hour)
Electrocardiograms (ECGs)
ECG monitoring
Time frame: 180 min after dosing
Electrocardiograms (ECGs)
ECG monitoring
Time frame: 720 min after dosing
Electrocardiograms (ECGs)
ECG monitoring
Time frame: 1440 min after dosing
Electrocardiograms (ECGs)
ECG monitoring
Time frame: 2160 min after dosing
Electrocardiograms (ECGs)
ECG monitoring
Time frame: 2880 min after dosing
Electrocardiograms (ECGs)
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.
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.
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.
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.
Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage
Time frame: 4 days after drug administration and blood sampling
The maximum plasma concentration
Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage
Time frame: 4 days after drug administration and blood sampling
The maximum plasma concentration
Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Deep phenotyping with genomics and functional genomics approaches
Time frame: Dosing(0 hour)
Deep phenotyping with genomics and functional genomics approaches
Time frame: 2880 min after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 8942688Aker PD, Gross AR, Goldsmith CH, Peloso P. Conservative management of mechanical neck pain: systematic overview and meta-analysis. BMJ. 1996 Nov 23;313(7068):1291-6.
- Background: PubMed 20091597Cui X, Trinh K, Wang YJ. Chinese herbal medicine for chronic neck pain due to cervical degenerative disc disease. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006556. doi: 10.1002/14651858.CD006556.pub2.
- BackgroundWang Q. Classification of the nine basic TCM constitutional type and based expression and diagnosis. Journal of Beijing University of Traditional Chinese medicine. 2005.1-8
- BackgroundLiu Mei, Zhang N, Wang YJ, Shi Q. Purification process research of major compound in Qishe Pill as Astragalus. Acta Chinese Medicine and Pharmacology. 2006(34):14-16.
- BackgroundZhang YQ, Liu XH, Zhang N, Liu M. Quality standard research of Qishe Pill. Lishizhen Med Mater Med Res. 2008(19): 977-979.
- BackgroundLiu M, Zhang N, Wang YJ, Zhang YQ, Zhou CJ. Technology research of Qishe Pill, a new medicine for cervical spondylosis. Lishizhen Med Mater Med Res. 2010(21):176-179.
- BackgroundGe JR, Wang HM, Meng CX, Tong PJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: a randomized controlled trial for Phase III. Chinese Journal of New Drugs and Clinical. 2014(7):56-58.
- Background: PubMed 15806754Johnson CL, Fulwood R, Abraham S, Bryner JD. Basic data on anthropometric measurements and angular measurements of the hip and knee joints for selected age groups 1-74 years of age. Vital Health Stat 11. 1981 Apr;(219):1-68. No abstract available.
- Background: PubMed 1755449Makela M, Heliovaara M, Sievers K, Impivaara O, Knekt P, Aromaa A. Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol. 1991 Dec 1;134(11):1356-67. doi: 10.1093/oxfordjournals.aje.a116038.
- Background: PubMed 8066508Bovim G, Schrader H, Sand T. Neck pain in the general population. Spine (Phila Pa 1976). 1994 Jun 15;19(12):1307-9. doi: 10.1097/00007632-199406000-00001.
- Background: PubMed 1795327van der Donk J, Schouten JS, Passchier J, van Romunde LK, Valkenburg HA. The associations of neck pain with radiological abnormalities of the cervical spine and personality traits in a general population. J Rheumatol. 1991 Dec;18(12):1884-9.
- BackgroundHsu H-Y: 1986 Oriental MateriaMedica. Long Beach, CA: Oriental Healing Arts Institute; 1986.
Related trials for Individuality
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Geolocation Positional System (GPS) Experience
Emotions, Anhedonia
Recruiting
Alcohol Sensitivity Among Older Adults Who Consume Alcohol
Healthy Adult Participants
RecruitingObservational study
Visual Perception, Binocular Rivalry, and Fatigue-Related Individual Differences in Colour and Illumination Judgement
Colour Perception, Color Perception
Recruiting
Interventions in Mathematics and Cognitive Skills
Math Learning Disability, Child Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue-Jun Cui, Dr. contact
Yue-li Sun, Dr contact
Yong-jun Wang, Dr. principal investigator
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Qishe Pill in people with Individuality and Narrative Medicine, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue-Jun Cui, Dr. (13917715524@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of Qishe Pill (time frame: Dosing(0 hour)). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294448, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.