Status:
COMPLETED
Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Lead Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Conditions:
Irritable Bowel Syndrome with Diarrhea
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types.
Detailed Description
The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up. Patient...
Eligibility Criteria
Inclusion
- The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
- It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
- Male or female aged 18 to 65 years (including the boundary value);
- The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
- IBS-SSS score\>175;
- Signed informed consent voluntarily.
Exclusion
- Patients with IBS-C、IBS-M or IBS-U；
- Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
- Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
- Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
- Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
- With history of abdominal surgery (e.g., cholecystectomy);
- Patients with severe cardiovascular disease, liver, kidney and other major organ diseases, hematopoietic system diseases, tumor, nervous or mental system diseases (such as severe depression, severe anxiety)
- Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected gastrointestinal motility and function ;
- Taking emergency medication in the run-in period；
- Pregnant or lactating women；
- Those who are allergic to the test drug, emergency drug and its ingredients；
- Suspected or confirmed history of alcohol and drug abuse;
- Patients who participated in other clinical trials within one month before enrollment;
- The researchers believe that others are not suitable for clinical trials.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04492787
Start Date
July 6 2020
End Date
April 21 2022
Last Update
September 5 2024
Active Locations (8)
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1
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Beijing, China
2
Shengjing Hospital of China Medical University
Dalian, China
3
Gansu Provincial Hospital of TCM
Gansu, China
4
The first affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hunan, China