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

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a traditional medicine called Baitouweng Decoction to see how effective it is for treating a specific type of ulcerative colitis (UC) known as large intestine damp-heat syndrome. This condition can cause symptoms like diarrhea, abdominal pain, and blood in the stool. The trial will use a new method to deliver the Baitouweng Decoction directly into the colon, which could help increase the medicine's effectiveness compared to taking it by mouth or using a rectal enema. Researchers aim to understand how this treatment works and its effects on the gut's bacteria.

To be eligible for the study, participants must be diagnosed with ulcerative colitis, currently experiencing mild to moderate symptoms, and have specific symptoms related to the damp-heat syndrome. They should also be able to tolerate the treatment and the procedures involved in the trial. Participants in the study can expect to receive close monitoring and care while exploring a potentially new way to manage their UC. This research could help develop better treatment options for people with this condition in the future.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients diagnosed with ulcerative colitis;
• • 2. The patients are in mild to moderate active stage with Mayo score of 3-8.
• • 3. Patients with damp-heat syndrome of large intestine according to TCM syndrome differentiation: according to the expert consensus on integrated traditional Chinese and Western medicine diagnosis and treatment of UC, the main symptoms are diarrhea, mucopurulent and bloody stool, abdominal pain, and tenesmus. Secondary symptoms: anal burning, body heat is not Yang, dry mouth and bitter mouth, short red urine. Tongue pulse: tongue red fur yellow greasy, pulse slippery number. The determination of the above 8 syndromes can be made if there are 2 main symptoms and 1-2 secondary symptoms. The tongue pulse is for reference only.
• • 4. The patients who can tolerate Baitouweng Decoction;
• • 5. The patients who tolerance to colonoscopy and TET;
• • 6. The patients who know and agree to participate in the clinical trial.
• Exclusion Criteria:
• • 1. The patients are complicated with other diseases that may cause diarrhea, such as infectious colitis, radiation enteritis, Crohn's disease, etc.
• • 2. Patients with heart, brain, lung, liver, kidney and other serious diseases;
• • 3. Patients do not cooperate to complete the clinical trial process;
• • 4. Other cases considered unsuitable for inclusion.