Evaluation of the efficacy and mechanism of New Wumei Pill in the treatment of mesalazine-refractory ulcerative colitis
- Conditions
- lcerative Colitis
- Registration Number
- ITMCTR2024000025
- Lead Sponsor
- Dongfang Hospital, Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1)The participants must meet the diagnostic criteria of mildly to moderately active ulcerative colitis.
(2)The participants have taken standard doses of 5-ASA continuously for more than 6 weeks or more.
(3)TCM syndrome type belongs to damp-heat stasis and spleen-kidney Yang deficiency.
(4)Their ages are between 18 and 65.
(5)The participants volunteer for this clinical trial and sign informed consents.
(1)Severely active UC.
(2)Pregnancy, lactation or preparing for pregnancy.
(3)Severe allergy or allergic to mesalazine or any of the ingredients in New Wumei Pill.
(4)Serious cardiovascular and cerebrovascular disease (chronic heart failure with New York Heart Association heart function above class ?, severe arrhythmia and severe stroke sequelae). Severe primary diseases of liver, kidney and hematology and so on.
(5)Serious complications, such as intestinal stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon or colorectal cancer, etc.
(6)Mental and intellectual disabilities.
(7)Have participated in other medical clinical studies in the last 3 months.
(8)Receive other treatments for ulcerative colitis other than mesalazine.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical efficiency rate;clinical remission rate;
- Secondary Outcome Measures
Name Time Method Mucosal healing rate;Quality of life assessment;Traditional Chinese Medicine syndrome score;single symptom score;Endoscopic response rate;