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

NCT05687435 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-01-18

No results posted yet for this study

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?

Conditions

  • Diarrhea-Predominant Irritable Bowel Syndrome

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.

Sponsors & Collaborators

  • Mei Han

    lead OTHER

Principal Investigators

  • Wei Wei, Pro · Wangjing Hospital of China Academy of Chinese Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-01-31
Completion
2024-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687435 on ClinicalTrials.gov