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COMPLETED
NCT05687435
PHASE4

Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Sponsor: Mei Han

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the efficacy and safety of the Chinese patent medicine Changyanning Tablet in the patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The main questions it aims to answer are: 1. Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients? 2. Is Changchangning Tablet safe for the treatment of IBS-D?

Official title: Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-01-30

Completion Date

2024-12-29

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

DRUG

Changyanning tablet

Changyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd,composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.

OTHER

Changyanning tablet placebo

Changyanning Tablet placebo is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd. Changyanning Tablet placebo has the same appearance, smell, taste, specifications and packaging with Changyanning Tablet, but does not contain active pharmaceutical ingredients. If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.

Locations (1)

Mei Han,Associate professor,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China