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

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

Timeline

Start

2021-01-21

Primary completion

2023-12

Completion

2024-01

Publications

• Background Suskind DL, Wahbeh G, Burpee T, Cohen M, Christie D, Weber W. Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):277-9. doi: 10.1097/MPG.0b013e318276977d.
• Background Hou L, Huang H. Immune suppressive properties of artemisinin family drugs. Pharmacol Ther. 2016 Oct;166:123-7. doi: 10.1016/j.pharmthera.2016.07.002. Epub 2016 Jul 10.
• Background Yang Z, Ding J, Yang C, Gao Y, Li X, Chen X, Peng Y, Fang J, Xiao S. Immunomodulatory and anti-inflammatory properties of artesunate in experimental colitis. Curr Med Chem. 2012;19(26):4541-51. doi: 10.2174/092986712803251575.

Drugs

Indications