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

Phase 2

• Conditions: Irritable Bowel Syndrome with Diarrhea
• Interventions: Drug: Changkang Placebo Granule; Drug: Changkang Granule

• Registration Number: NCT04492787
• Lead Sponsor: Tasly Pharmaceutical Group Co., Ltd

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.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-06
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2022-06-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Changkang Placebo Granules	Changkang Placebo Granule	Changkang Placebo Granules
Changkang Granules	Changkang Granule	Changkang Granules

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Are Composite Responders Consistency Scores	8 week	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.; 1. Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; 2. 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline to each week during follow up for IBS-symptoms abdominal pain；	8 week	Abdominal Pain：Scored between 0 and 10 (none to severe).
Change from baseline to each week during follow up for IBS-symptoms Defecation frequency	8 week	Change from baseline in mean number of bowel movements per week.
Percentage of Participants Who Are Responders in Abdominal Pain Scores	8 week	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.
Change from baseline to each week during follow up for IBS-symptoms bloating	8 week	Bloating：Scored between 0 and 10.
Change from baseline to each week during follow up for IBS-symptoms urgency	8 week	The change of frequency of defecation urgency per week compared with baseline.
Percentage of Participants Who Are Responders in Stool Consistency Scores	8 week	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.
Change from baseline to each week during follow up for IBS-symptoms stool consistency;	8 week	Stool consistency：Bristol Stool Scale（Scored 1-7）.
Disappearance rate of traditional Chinese Medicine（TCM）symptom	8 week	Each syndrome type has 2-3 symptoms，liver Qi multiplying spleen syndrome includes Chest and flank fullness, depression, irritability

Trial Locations

Locations (8)

Xiyuan Hospital, China Academy of Traditional Chinese Medicine; 🇨🇳 Beijing, China

Shengjing Hospital of China Medical University; 🇨🇳 Dalian, China

Gansu Provincial Hospital of TCM; 🇨🇳 Gansu, China

The first affiliated Hospital of Hunan University of Traditional Chinese Medicine; 🇨🇳 Hunan, China

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China

West China Hospital of Sichuan University; 🇨🇳 Sichuan, China

Wenzhou Hospital of Traditional Chinese Medicine; 🇨🇳 Wenzhou, China

Xiamen Hospital of Traditional Chinese Medicine; 🇨🇳 Xiamen, China