ITMCTR2100005038Not yet recruiting未知
Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials
The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 75 (—)
- Sex
- All
Inclusion Criteria
- •(1) Patients in remission who meet the diagnostic criteria for UC;
- •(2) The classification belongs to E2 or E3 type, that is, the lesion range is sigmoid colon type, or sigmoid colon type combined with rectal type;
- •(3) Meet the diagnostic criteria of TCM syndrome of spleen deficiency and dampness accumulation.
- •2. Aged 18 to 75 years old;
- •3. Patients who signed informed consent.
Exclusion Criteria
- •1. Active UC patients, severe UC patients who need systemic hormones (intravenous or oral); the classification belongs to E1 type, that is, the lesions are patients with pure rectal type;
- •2. Bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis and other infectious colitis and Crohn's disease, ischemic enteritis, radiation enteritis patients; colon cancer, rectal cancer patients;
- •3. Patients with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal adenoma, toxic colonic dilatation, and anal disease;
- •4. Pregnant or lactating women;
- •5. Allergic constitution or allergic history to multiple drugs (more than 2 kinds or known ingredients in the prescription), allergic to aminosalicylic acid drugs;
- •6. Have serious primary cardiovascular, respiratory and blood system diseases;
- •7. Serum creatinine (Cr) is higher than the upper limit of the normal value, and liver function alanine aminotransferase (ALT) is more than 2 times the normal value;
- •8. Male patients with fertility requirements;
- •9. Patients who participated in clinical trials of other drugs within 3 months;
- •10. Other conditions that the doctor considers inappropriate as a subject.
Investigators
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