NCT06753890

Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern)

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Efficacy and Safety Study of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea ( Liver qi Affecting the Spleen Pattern)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)

Detailed description

This Randomized, Double-blind, Placebo-controlled, Multicenter Phase III clinical trial will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)

Conditions

• Diarrhea-predominant Irritable Boewl Syndrome

Interventions

Type	Name	Description
DRUG	Changkang granules	7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
DRUG	Changkang Granules placebo	7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-11-11
• Completion: 2026-12-30
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

30 sites across 1 country: China