CompletedPhase 2

Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

China240 participantsStarted 2020-07-06

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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 ;

What they're measuring

Percentage of Participants Who Are Composite Responders Consistency Scores

Timeframe: 8 week

Trial details

NCT IDNCT04492787

SponsorTasly Pharmaceutical Group Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-21

View on ClinicalTrials.gov More Irritable Bowel Syndrome with Diarrhea trials