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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Drug: Changkang Granule
* Drug: Changkang Placebo Granule


Participation Criteria
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Eligibility Criteria
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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 ; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Changkang Granules<br>Changkang Granules | Drug: Changkang Granule<br>* Take Changkang granule before meals twice a day , one bag for each time<br>|
| Placebo Comparator: Changkang Placebo Granules<br>Changkang Placebo Granules | Drug: Changkang Placebo Granule<br>* Take Changkang Placebo granule before meals twice a day , one bag for each time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Composite Responders Consistency Scores | Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval. The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week. Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Responders in Abdominal Pain Scores | Abdominal pain responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval; Weekly response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline. | 8 week | 
| Percentage of Participants Who Are Responders in Stool Consistency Scores | Stool consistency responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval. Weekly response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. | 8 week | 
| Change from baseline to each week during follow up for IBS-symptoms abdominal pain； | Abdominal Pain：Scored between 0 and 10 (none to severe). | 8 week | 
| Change from baseline to each week during follow up for IBS-symptoms stool consistency; | Stool consistency：Bristol Stool Scale（Scored 1-7）. | 8 week | 
| Change from baseline to each week during follow up for IBS-symptoms bloating | Bloating：Scored between 0 and 10. | 8 week | 
| Change from baseline to each week during follow up for IBS-symptoms urgency | The change of frequency of defecation urgency per week compared with baseline. | 8 week | 
| Change from baseline to each week during follow up for IBS-symptoms Defecation frequency | Change from baseline in mean number of bowel movements per week. | 8 week | 
| Disappearance rate of traditional Chinese Medicine（TCM）symptom | Each syndrome type has 2-3 symptoms，liver Qi multiplying spleen syndrome includes Chest and flank fullness, depression, irritability | 8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Changkang Granule