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Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis - Trial NCT06421818

Access comprehensive clinical trial information for NCT06421818 through Pure Global AI's free database. This Phase 2 trial is sponsored by The Second Hospital of Nanjing Medical University and is currently Recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 144 participants.

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NCT06421818
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06421818
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DJ Fang

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Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
Formula-to-Syndrome Effect and Pharmacomicrobiomics Mechanism of Colon Delivery of Baitouweng Decoction for Treating Large Intestine Damp-heat Syndrome of Ulcerative Colitis

Study Focus

Ulcerative Colitis

Baitouweng Tang

Interventional

drug

Sponsor & Location

The Second Hospital of Nanjing Medical University

Nanjing, China

Timeline & Enrollment

Phase 2

May 01, 2024

Dec 30, 2026

144 participants

Primary Outcome

The change of fecal calprotecin.

Summary

Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of
 ulcerative colitis (UC) by oral administration and rectal enema.The project applicant's
 invention of transendoscopic entral tubing (TET) has been used in Baitouweng Decoction for
 the treatment of UC across the whole colon, however, the efficacy have not been reported and
 the underlying mechanism is still unclear. Compared with oral and rectal enema, Baitouweng
 Decoction by colon TET can improve the therapeutic effect by increasing the concentration of
 drugs in the whole colon, which need to be verified. This project will reveal the
 prescription effect and drug-microbiome interaction mechanism of whole colon repeated
 administration of Baitouweng Decoction in the treatment of UC through clinical randomized
 controlled studies, deep intestinal dynamic sampling, integrated analysis of multi-omics and
 TCM prescription metabolomics studies, and provide key scientific basis for the establishment
 of a new approach of whole colon repeated administration of TCM and a new strategy for the
 treatment of UC.

ICD-10 Classifications

Ulcerative colitis
Other ulcerative colitis
Ulcerative colitis, unspecified
Arthropathy in ulcerative colitis
Juvenile arthritis in ulcerative colitis

Data Source

ClinicalTrials.gov

NCT06421818

Non-Device Trial