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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948870
First Posted: July 29, 2009
Last Update Posted: March 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Indicates of liver and renal function [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00948870     History of Changes
Other Study ID Numbers: SHTCM-002
First Submitted: July 28, 2009
First Posted: July 29, 2009
Last Update Posted: March 7, 2013
Last Verified: August 2009

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

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