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New treatment option for Ulcerative Colitis
Official title Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
ClinicalTrials.gov ID: NCT06421818
What this study is testing
What is Baitouweng Tang?
Baitouweng Tang is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
Also referred to as Baitouweng Decoction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
- The patients who can tolerate Baitouweng Decoction;
- The patients who tolerance to colonoscopy and TET;
You likely can't join if
- The patients are complicated with other diseases that may cause diarrhea, such as infectious colitis, radiation enteritis, Crohn's disease, etc.
- Patients with heart, brain, lung, liver, kidney and other serious diseases;
- Patients do not cooperate to complete the clinical trial process;
- Other cases considered unsuitable for inclusion.
See the full eligibility criteria
- 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...
- The patients who can tolerate Baitouweng Decoction;
- The patients who tolerance to colonoscopy and TET;
- The patients who know and agree to participate in the clinical trial.
- The patients are complicated with other diseases that may cause diarrhea, such as infectious colitis, radiation enteritis, Crohn's disease, etc.
- Patients with heart, brain, lung, liver, kidney and other serious diseases;
- Patients do not cooperate to complete the clinical trial process;
- Other cases considered unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.