A Multicenter, Randomized and Controlled Trial for Chang-An-Jun-Tai Granule in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D).
- Conditions
- Irritable bowel syndrome
- Registration Number
- ITMCTR1900002644
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
To simultaneously satisfy the following criteria:
1. Conform to the Roman IV(Rome IV) of a patient diagnosed with IBS-D and baseline IBS-SSS score > 75;
2. Aged 18 to 60 years;
3. Nearly 2 weeks no using the drugs in the treatment of IBS;
4. Nearly 2 weeks no using antibiotics or probiotics;
5. The patients volunteered to receive the drug and signed an informed consent form, and the informed consent process was in accordance with the relevant provisions of GCP.
Meet one of the following criteria were excluded:
1. there is explanation above the clinical symptoms of the patients with other diseases;
2. chronic esophagitis, Barrett esophagus and gastroesophageal reflux disease, peptic ulcer, gastric polyp (without resection), digestive tract tumor patients;
3. found that endoscopic gastric mucosa high grade intraepithelial neoplasia, pathological diagnosis, malignant gastrointestinal organic diseases;
4. patients with history of abdominal operation;
5. allergic or allergic to many medicines;
6. confusion, dementia, psychosis, neurosis and various serious unwilling to cooperate;
7. with serious the primary cardiovascular disease, liver disease, kidney disease, blood disease, lung disease, autoimmune diseases, or serious diseases affected the survival, such as cancer or aids;
8. pregnant and lactating women;
9. exist cognitive or other damage (such as vision, etc.) and impact on the participants completed self-report;
10. of the pharmaceutical composition ingredients allergies are; is or 4 weeks in other drug clinical trials of patients;
11. investigators have sufficient reason to believe that the participants according to current medical or psychological state is not suitable for researchers to study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate of IBS-SSS scale;
- Secondary Outcome Measures
Name Time Method Intestinal flora;Metabonomics;IBS-SSS;HAD;IBS-QOL;AR response rate;