NCT06421818 Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
| NCT ID | NCT06421818 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-05 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 144 participants in total. It began in 2024-05 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Faming Zhang, PhD
PRINCIPAL INVESTIGATOR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06421818 clinical trial?
This trial is open to participants of all sexes, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06421818 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06421818 currently recruiting?
Yes, NCT06421818 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT06421818 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06421818 clinical trial?
NCT06421818 is sponsored by The Second Hospital of Nanjing Medical University. The principal investigator is Faming Zhang, PhD at The Second Hospital of Nanjing Medical University. The trial plans to enroll 144 participants.
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