Status:
UNKNOWN
PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Conditions:
Individuality
Narrative Medicine
Eligibility:
All Genders
20-35 years
Phase:
PHASE1
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 Calcul...
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...
Eligibility Criteria
Inclusion
- Inclusion
- Aged 20-35
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02294448
Start Date
November 1 2014
End Date
July 1 2016
Last Update
November 19 2014
Active Locations (1)
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1
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, China, 200032