Using Baitouweng Decoction to treat 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

This study is testing if a traditional herbal remedy called Baitouweng Decoction can help people with ulcerative colitis by trying it in different ways, like taking it by mouth or as an enema, to see which method works best.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06421818 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Baitouweng Decoction in treating large intestine damp-heat syndrome associated with ulcerative colitis. It employs a multi-center randomized controlled design to compare the outcomes of three different administration methods: colon transendoscopic entral tubing (TET), rectal enema, and oral intake. The study will analyze changes in fecal calprotectin levels, disease condition, and safety over a treatment period of 10 days, while also examining the microbiome and metabolomic changes associated with the treatment. A total of 144 subjects will be enrolled and divided into treatment and placebo groups to assess the efficacy and underlying mechanisms of the decoction.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with mild to moderate active ulcerative colitis who exhibit symptoms of large intestine damp-heat syndrome.

Not a fit: Patients with severe ulcerative colitis or those who do not meet the specific syndrome criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from ulcerative colitis.

How similar studies have performed: While the use of Baitouweng Decoction is traditional, this specific approach using colon TET is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Nanjing, Jiangsu

• Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Faming Zhang, PhD — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, PhD

Conditions Ulcerative Colitis; Baitouweng Decoction; Formula-to-Syndrome Effect; Ulcerative colitis; Pharmacomicrobiomics; Colon delivery