NCT00948870CompletedNot Applicable
Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）
Shanghai University of Traditional Chinese Medicine1 site in 1 country200 target enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Symptoms and conditions of tongue and pulse
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndrome（diarrhea type）.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of irritable bowel syndrome（diarrhea type）
- •Male of female patients between 18-65 years old
- •Written informed consent
Exclusion Criteria
- •Discrepancy of irritable bowel syndrome
- •Diarrhea-type of irritable bowel syndrome combine with intestinal disease
- •Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- •Pregnancy or breast feeding women, or unwilling to have contraception.
Arms & Interventions
Shugan Decoction
Experimental
Intervention: Shugan decoction (Drug)
low does of Shugan decoction
Placebo Comparator
Intervention: Shugan decoction (Drug)
Outcomes
Primary Outcomes
Symptoms and conditions of tongue and pulse
Time Frame: 4 weeks
Secondary Outcomes
- Indicates of liver and renal function(4 weeks)
Investigators
Study Sites (1)
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