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

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ClinicalTrials.gov Identifier: NCT00948870
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Traditional Chinese Medicine Drug: Shugan decoction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Symptoms and conditions of tongue and pulse [ Time Frame: 4 weeks ]

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


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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.

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

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00948870     History of Changes
Other Study ID Numbers: SHTCM-002
First Posted: July 29, 2009    Key Record Dates
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