Back to resultsTrial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）
Primary Purpose
Irritable Bowel Syndrome, Traditional Chinese Medicine
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Shugan decoction
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring alternative medicine
Eligibility 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.
Sites / Locations
- Longhua hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Shugan Decoction
low does of Shugan decoction
Arm Description
Outcomes
Primary Outcome Measures
Symptoms and conditions of tongue and pulse
Secondary Outcome Measures
Indicates of liver and renal function
Full Information
NCT ID
NCT00948870
First Posted
July 28, 2009
Last Updated
March 6, 2013
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00948870
Brief Title
Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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）.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Traditional Chinese Medicine
Keywords
alternative medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shugan Decoction
Arm Type
Experimental
Arm Title
low does of Shugan decoction
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Shugan decoction
Intervention Description
Decoction ,two times a day,one bag of decoction one time
Primary Outcome Measure Information:
Title
Symptoms and conditions of tongue and pulse
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Indicates of liver and renal function
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xie Jianqun, Phd
Organizational Affiliation
Shanghai University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Longhua hospital
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）
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