Effects of the Renzhuchangle granule on diarrhoea-predominant irritable bowel syndrome
- Conditions
- Diarrhoea-predominant irritable bowel syndrome (IBS-D)Digestive System
- Registration Number
- ISRCTN42639030
- Lead Sponsor
- Purapharm (Nanning) Pharmaceuticals Co. Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 108
1. Diarrhoea-predominant irritable bowel syndrome (IBS-D) meeting the Rome IV criteria
2. Meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria
3. Aged 18 to 65
4. Voluntary acceptance of the medication
5. Signed informed consent
6. Average daily worst abdominal pain score =3 during the last week of screening phase
7. More than two days of =1 loose stools (Bristol Stool Scale 6 or 7) during the last week of screening phase
1. Prior abdominal surgery which may cause bowel symptoms similar to IBS
2. Diarrhoea as a result of any of the following:
2.1. Infection
2.2. Systemic diseases
2.3. Poisoning
2.4. Cancer
3. Serious concomitant diseases, including cardiovascular, renal, hepatic, respiratory, neurological, endocrine or haematopoietic diseases
4. History of alcohol or drug abuse
5. Allergic constitution or known to be allergic to the drug used in this trial
6. Involved in other trials
7. Pregnant or breastfeeding, or plan to become pregnant soon
8. Poor compliance or any other reason the research believers they may not be appropriate to participate in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method