Treatment of Jianpi Shugan recipe in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D)

Completed

• Conditions: Diarrhoea-predominant irritable bowel syndrome (IBS-D); Digestive System; Irritable bowel syndrome with diarrhoea

• Registration Number: ISRCTN66631530
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-08
• Last Update Posted: 6 July 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Patients with IBS-D meeting the Rome III criteria
2. Patients meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria
3. Patients able to give informed consent
4. Female patients of childbearing potential are willing to use at least one highly effective contraceptive method
5. Aged 18-65 years, either sex

Exclusion Criteria

1. Women who are pregnant or breastfeeding
2. Prior abdominal surgery which may cause bowel symptoms similar to IBS
3. Patients with the following diarrhea conditions: infection, systemic diseases, poisoning or cancer
4. Patients with serious concomitant diseases e.g. cardiovascular, renal, hepatic, respiratory, neurological, endocrine, hematopoietic etc
5. Patients with a history of alcoholic or drug abuse
6. Patients who have allergic constitution or known to be allergic to the drug used in this trial
7. Patients who are involved in other trials
8. Patients with poor compliance or other reasons that the researcher considered not to be appropriate to participate in this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS Symptom Severity Score (IBS-SSS) measured at baseline, 2 weeks and 4 weeks

Secondary Outcome Measures

Name	Time	Method
1. Traditional Chinese Medicine syndromes of IBS score measured at baseline, 2 weeks and 4 weeks<br>2. Defection state questionnaire (DSQ) for IBS noted by patients daily<br>3. Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) at baseline and 4 weeks<br>4. Serum concentration of serotonin at baseline and 4 weeks