Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
Phase 2 · Testing Baitouweng Tang · 1 site · The Second Hospital of Nanjing Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Baitouweng Tang (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Age range not stated in the record
- Any sex
Some of the main requirements, copied from the record:
- Patients diagnosed with ulcerative colitis;
- The patients are in mild to moderate active stage with Mayo score of 3-8.
- 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…
Plus 3 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 144 participants are expected to take part.
- Start date: 2024-05 (planned).
- Main results expected around 2026-12-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The concentration of fecal calprotecin. (Baseline; Day 15; Day 53)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | The Second Hospital of Nanjing Medical University |
| Collaborators | Heilongjiang University of Chinese Medicine |
| Enrollment | 144 (estimated) |
| Start date | 2024-05 |
| Primary completion (est.) | 2026-12-30 |
| First posted | 2024-05-20 |
| Last updated | 2024-05-21 |
| Official title | Formula-to-Syndrome Effect and Pharmacomicrobiomics Mechanism of Colon Delivery of Baitouweng Decoction for Treating Large Intestine Damp-heat Syndrome of Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06421818 |
Interventions
- Baitouweng Tang (Drug)
Baitouweng Decoction is composed of four herbs: Baitouweng, Rhizoma coptidis, Phellodendri huangbai and Qin Pi. - Placebo (Other)
The same volume and color as Baitouweng Decoction.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing, Jiangsu | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.