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