Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type
- Conditions
- icerative colitis
- Registration Number
- ITMCTR2000003714
- Lead Sponsor
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. According to the diagnostic criteria of Western medicine for ulcerative colitis, the clinical severity is mild to moderate; the lesions include rectum, left colon or extensive colon; the clinical types are primary or chronic relapse;
2. TCM syndrome differentiation belongs to spleen deficiency damp heat type;
3. They are between 18 and 75 years old;
4. The patient voluntarily participated in the clinical trial and signed the informed consent.
1. Patients with chronic persistent, fulminant and severe ulcerative colitis.
2. Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis.
3. Patients have serious complications, such as local stenosis, intestinal perforation, intestinal obstruction, massive hemorrhage, toxic megacolon, colorectal cancer and so on.
4. Combined with heart, liver, kidney, hematopoietic system, endocrine system and other serious primary diseases and mental patients.
5. Pregnant or preparing pregnant women, lactating women, allergic constitution and allergic to this drug.
6. Those who have been treated with hormone therapy or other related drugs or are participating in other clinical trials.
7. Suspected or confirmed history of alcohol and drug abuse.
8. Those who do not cooperate with the treatment and cannot judge the curative effect.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical efficacy rate;
- Secondary Outcome Measures
Name Time Method laboratory index;endoscopic response rate;mucosal healing rate;quality of life;TCM syndrome efficacy;clinical remission rate;emotion evaluation;