Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials

Not Applicable

• Conditions: lcerative Colitis

• Registration Number: ITMCTR1900002423
• 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. patients with UC in the remission phase (determined by a UC Disease Activity Index score of 0–2 and bloody stool score of 0); the extent of UC is limited to left sided colitis and extensive colitis (Montreal classificati on E2, E3); the TCM syndrome was dampness stagnancy due to spleen deficiency syndrome;
2. men or women aged between 18 and 75 years;
3. participants voluntarily participated in this study, signed informed consent, and had good compliance.

Exclusion Criteria

1. patients with active UC, severe UC, or acute fulminating type UC;
2. patients undergoing treatment with corticosteroids (oral, enemas, suppository, injectable solution);
3. patients treated with blood cell apheresis;
4. patients who were administered anti-tumor necrosis factor-a antibody within 90 days before starting the study drug;
5. patients with history of hypersensitivity to mesalazine and salicylic acid;
6. patients with serious cardiovascular disease, hemodyscrasia, or lung disease or with a history of these conditions;
7. patients with liver disease or kidney disease;
8. patients with malignant tumor as a complication;
9. pregnant women or those who were breastfeeding;
10. other conditions that the researcher don't consider it was suitable.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (diarrhea, abdominal pain, mucus stool, bloody purulent stool);

Secondary Outcome Measures

Name	Time	Method
TCM Syndrome Scale;The Short Inflammatory Bowel Disease Questionnaire (SIBDQ);The Short Health Scale (SHS);The Rating Form of IBD Patient Concerns (RFIPC);