Actively Recruiting
Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
Led by The Second Hospital of Nanjing Medical University · Updated on 2024-05-21
144
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
T
The Second Hospital of Nanjing Medical University
Lead Sponsor
H
Heilongjiang University of Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with ulcerative colitis
- Mild to moderate active ulcerative colitis with Mayo score of 3-8
- Large intestine damp-heat syndrome according to traditional Chinese medicine diagnosis, including 2 main symptoms (diarrhea, mucopurulent and bloody stool, abdominal pain, tenesmus) and 1-2 secondary symptoms (anal burning, body heat not Yang, dry mouth, bitter mouth, short red urine)
- Tolerance to Baitouweng Decoction
- Tolerance to colonoscopy and transendoscopic enteral tubing (TET)
- Willingness and ability to participate in the clinical trial
You will not qualify if you...
- Presence of other diseases causing diarrhea such as infectious colitis, radiation enteritis, Crohn's disease
- Serious heart, brain, lung, liver, kidney, or other diseases
- Inability or unwillingness to complete the clinical trial process
- Other conditions deemed unsuitable for inclusion by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
F
Faming Zhang, PhD
CONTACT
B
Bota Cui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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