Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center phase 2a, randomised double-blind, placebo-controlled factorial design, proof of concept trial. Patients with Crohn's disease who are on an adequate dose of azathioprine and still continue to active disease (CDAI > 150 and c-reactive protein > 6) will be enrolled. Forty patients will be randomised in a 1:1:1:1 ratio into 4 groups in a 2x2 factorial design to receive artesunate 200 mg PO daily for 2 weeks and / or Curcumin 2 gm PO daily for 3 months or placebo. Treatment Curcumin x 13 weeks Placebo C x 13 weeks Artesunate x 2 weeks Group 1 Group 2 Placebo A x 2 weeks Group 3 Group 4 During the treatment period and follow up period patients will be continued on their regular dose of azathioprine and 5-aminosalicylic acid with no change allowed during the study period. Patients will maintain a daily diary of symptoms and adverse events. Scheduled hospital visits with blood and stool tests will be at baseline, week 1, month 1, month 3 and month 6. Primary endpoint will be remission (defined as CDAI < 150) at 3 months

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Collaborator: St George's University of London, London, UK
• Treatments: Artesunate; Curcumin

Criteria

Inclusion Criteria:

• Men or women with a diagnosis of Crohn's disease who are being treated with an adequate, constant dose of azathioprine for at least 3 months (adequate dose is 1 mg/kg in those with low Thiopurine methyltransferase, 2 mg per kg in those with normal Thiopurine methyltransferase)

• Age 18 to 65 yrs

• Crohn's disease of mild to moderate activity (CDAI 150 to 450) and c-reactive protein > 6

• Hemoglobin >9, white blood cells > 3500, platelets > 1,00,000

• Bilirubin < 3, alanine transaminase < 3x upper limit of normal

• Glomerular filtration rate >45

• Normal electrocardiogram

Exclusion Criteria:

• Pregnancy, women who are planning to get pregnant and those unwilling to use contraception

• Lactation

• Bowel surgery with the past 3 months

• Intra-abdominal abscess

• Ileostomy or colostomy

• Change in dose of 5-aminosalicylic acid in the past 4 weeks

• Use of corticosteroids within the past 4 weeks