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NCT06421818Recruiting

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
The Second Hospital of Nanjing Medical UniversityPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Baitouweng Tang
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
The Second Hospital of Nanjing Medical University
Location
Nanjing, China
Timeline & enrollment
Phase
Phase 2
Start date
May 01, 2024
End date
Dec 30, 2026
Enrollment
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 colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421818
Type
Non-Device Trial
About this record

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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