NCT06319729

A Chinese Herbal Medicine for IBS-C

The Efficacy and Safety of a Chinese Herbal Medicine for the Constipation-predominant Irritable Bowel Syndrome (IBS-C): a Double-blinded, Placebo-controlled, Randomized Pilot Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.

Detailed description

This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.Primary Objective: To determine the efficacy and safety of CDD-2105 granules for treating IBS-C.

Conditions

• Constipation-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	CDD-2105	A Chinese herbal medicine formula containing four granular herbs.
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-03-25
• Primary completion: 2024-08-31
• Completion: 2024-11-30
• First posted: 2024-03-20
• Last updated: 2024-03-21