Clinical trial NCT04492787: Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Official title: A Randomized,double-blind,placebo-controlled,multicenter Study to Evaluate the Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome with Diarrhea
Keywords: Changkang Granule
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Patients report their IBS-related symptoms daily from run-in until end of treatment.

Eligibility criteria: Inclusion Criteria:

1. The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
2. 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;
3. Male or female aged 18 to 65 years (including the boundary value);
4. 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;
5. IBS-SSS score\>175;
6. Signed informed consent voluntarily.

Exclusion Criteria:

1. Patients with IBS-C、IBS-M or IBS-U；
2. 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;
3. Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
4. Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
5. Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
6. With history of abdominal surgery (e.g., cholecystectomy);
7. 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)
8. 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 ;
9. Taking emergency medication in the run-in period；
10. Pregnant or lactating women；
11. Those who are allergic to the test drug, emergency drug and its ingredients；
12. Suspected or confirmed history of alcohol and drug abuse;
13. Patients who participated in other clinical trials within one month before enrollment;
14. The researchers believe that others are not suitable for clinical trials.

Primary outcomes:
measure: Percentage of Participants Who Are Composite Responders Consistency Scores
timeFrame: 8 week
Secondary outcomes:
measure: Percentage of Participants Who Are Responders in Abdominal Pain Scores
timeFrame: 8 week
measure: Percentage of Participants Who Are Responders in Stool Consistency Scores
timeFrame: 8 week
measure: Change from baseline to each week during follow up for IBS-symptoms abdominal pain；
timeFrame: 8 week
measure: Change from baseline to each week during follow up for IBS-symptoms stool consistency;
timeFrame: 8 week
measure: Change from baseline to each week during follow up for IBS-symptoms bloating
timeFrame: 8 week
measure: Change from baseline to each week during follow up for IBS-symptoms urgency
timeFrame: 8 week
measure: Change from baseline to each week during follow up for IBS-symptoms Defecation frequency
timeFrame: 8 week
measure: Disappearance rate of traditional Chinese Medicine（TCM）symptom
timeFrame: 8 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Traditional Chinese Medicine
city: Dalian
country: China
facility: Shengjing Hospital of China Medical University
city: Gansu
country: China
facility: Gansu Provincial Hospital of TCM
city: Hunan
country: China
facility: The first affiliated Hospital of Hunan University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
city: Wenzhou
country: China
facility: Wenzhou Hospital of Traditional Chinese Medicine
city: Xiamen
country: China
facility: Xiamen Hospital of Traditional Chinese Medicine
Study officials:
References: