Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials

Not Applicable

• Conditions: lcerative Colitis

• Registration Number: ITMCTR2100005038
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.
(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified