Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease
Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences