Status:
UNKNOWN
Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Collaborating Sponsors:
St George's University of London, London, UK
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 st...
Detailed Description
Primary objective: To study the safety, tolerability and efficacy of Artesunate and Curcumin in patients with Crohn's disease, who have ongoing clinical and biochemical evidence of disease activity de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04713631
Start Date
January 21 2021
End Date
January 1 2024
Last Update
May 23 2023
Active Locations (1)
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1
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, India, 226014