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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00948870
First received: July 28, 2009
Last updated: March 6, 2013
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndrome（diarrhea type）.


Condition Intervention
Irritable Bowel Syndrome
Traditional Chinese Medicine
 Drug: Shugan decoction

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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Symptoms and conditions of tongue and pulse [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Indicates of liver and renal function [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shugan Decoction Drug: Shugan decoction
Decoction ,two times a day,one bag of decoction one time
Placebo Comparator: low does of Shugan decoction Drug: Shugan decoction
Decoction ,two times a day,one bag of decoction one time

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948870

Locations
China, Shanghai
Longhua hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Study Director: Xie Jianqun, Phd Shanghai University of Chinese Medicine
  More Information

No publications provided

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00948870     History of Changes
Other Study ID Numbers: SHTCM-002
Study First Received: July 28, 2009
Last Updated: March 6, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:
alternative medicine

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013