NCT04492787

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome with Diarrhea

Interventions

Type	Name	Description
DRUG	Changkang Granule	Take Changkang granule before meals twice a day , one bag for each time
DRUG	Changkang Placebo Granule	Take Changkang Placebo granule before meals twice a day , one bag for each time

Timeline

• Start date: 2020-07-06
• Primary completion: 2022-04-21
• Completion: 2022-04-21
• First posted: 2020-07-30
• Last updated: 2024-09-05

Locations

8 sites across 1 country: China