Ulcerative Colitis
Conditions
Interventions
Mesalazine enteric-coated tablets+New Wumei Pill:drug
Mesalazine enteric-coated tablets+Dummy New Wumei Pill:placebo
Sponsors
Dongfang Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical efficiency rate;clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mucosal healing rate;Quality of life assessment;Traditional Chinese Medicine syndrome score;single symptom score;Endoscopic response rate; | — |
Countries
China
Contacts
Public ContactTangyou Mao
Dongfang Hospital, Beijing University of Chinese Medicine
Outcome results
None listed