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

NCT04492787 | Completed Phase 2

• 1 other identifier: TSL-TCM-CKKL-Ⅱ
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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.

Conditions

Irritable Bowel Syndrome with Diarrhea

Keywords

Changkang Granule

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  8 week

Secondary Outcomes (8)

• Percentage of Participants Who Are Responders in Abdominal Pain Scores

  8 week

• Percentage of Participants Who Are Responders in Stool Consistency Scores

  8 week

• Change from baseline to each week during follow up for IBS-symptoms abdominal pain；

  8 week

• Change from baseline to each week during follow up for IBS-symptoms stool consistency;

  8 week

• Change from baseline to each week during follow up for IBS-symptoms bloating

  8 week

Study Arms (2)

Changkang Granules

EXPERIMENTAL

Changkang Granules

Drug: Changkang Granule

Changkang Placebo Granules

PLACEBO COMPARATOR

Changkang Placebo Granules

Drug: Changkang Placebo Granule

Interventions

Changkang Granule DRUG

Take Changkang granule before meals twice a day , one bag for each time

Changkang Granules

Changkang Placebo Granule DRUG

Take Changkang Placebo granule before meals twice a day , one bag for each time

Changkang Placebo Granules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (8)

Xiyuan Hospital, China Academy of Traditional Chinese Medicine

Beijing, China

Location

Shengjing Hospital of China Medical University

Dalian, China

Location

Gansu Provincial Hospital of TCM

Gansu, China

Location

The first affiliated Hospital of Hunan University of Traditional Chinese Medicine

Hunan, China

Location

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

West China Hospital of Sichuan University

Sichuan, China

Location

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, China

Location

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: July 6, 2020
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)