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NCT00948870 Clinical Trial

Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00948870
Other study ID # SHTCM-002
Secondary ID
Status Completed
Phase N/A
First received July 28, 2009
Last updated March 6, 2013
Start date August 2009
Est. completion date September 2011

Study information
Verified date August 2009
Source Shanghai University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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）.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Shugan decoction
Decoction ,two times a day,one bag of decoction one time

Locations
Country Name City State
China Longhua hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms and conditions of tongue and pulse 4 weeks No
Secondary Indicates of liver and renal function 4 weeks Yes
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