Overview

Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

Status:
Unknown status
Trial end date:
2021-04-01
Target enrollment:
0
Participant gender:
All
Summary
UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The efficacy of mesalazine in preventing relapse in patients with UC is well-known and supported by randomized studies. However, mesalazine can be associated with side-effects. In addition, drug compliance is suboptimal, especially when disease is not active. Curcumin is a natural phytochemical derived from the Indian spice turmeric. It is widely used, has potent anti-inflammatory, anti-oxidant and anti-tumour properties. The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese University of Hong Kong
Treatments:
Curcumin
Criteria
Inclusion Criteria:

- in clinical remission for at least 1 month, defined as Mayo bowel frequency subscore ≤
1 and Mayo rectal bleeding subscore = 0 (Table 2).

- a history of at least one flare with symptoms that required intervention within 24
months before screening

- age ≥ 18

- written informed consent obtained

Exclusion Criteria:

- receipt of immunosuppressive drugs or corticosteroids within 60 days of screening

- prior bowel surgery except appendectomy

- with severe relapse (Mayo score 9-12) in the last 3 months

- History or evidence of incompletely resected colonic mucosal dysplasia

- on regular curcumin supplements or intake of curry in diet for ≥5 days each week

- presence of infections (exclude simple infections such as influenza, etc.) or sepsis

- pregnancy or lactating women

- with a Mayo endoscopic subscore ≥2 on sigmoidoscopy or colonoscopy at baseline

- allergic to curry-related products