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

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ClinicalTrials.gov Identifier: NCT04713631
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
St George's University of London, London, UK
Information provided by (Responsible Party):
Sanjay Gandhi Postgraduate Institute of Medical Sciences

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 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

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Artesunate Drug: Curcumin Drug: Placebo A Drug: Placebo C Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Phase 2a Randomised Double-blind Placebo-controlled Trial to Assess Safety, Efficacy of Artesunate & Curcumin in Crohn's Disease Patients, Who Continue to Have Mild to Moderate Disease Activity on an Adequate Dose of Azathioprine
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: Artesunate and Curcumin
Artesunate 200 mg PO once a day x 2 weeks. Curcumin 2 gm PO once a day x 13 weeks.
Drug: Artesunate
Artesunate is approved for the treatment of malaria and is on the World Health Organization list of Essential Medicines. Artesunate has a hemisuccinate group which confers substantial water-solubility and high oral bioavailability and therefore a convenient oral route of administration. Artesunate has a good safety and tolerability profile, having been used to treat millions of adults and children globally.

Drug: Curcumin
Curcumin has been used in Indian cuisine and traditional medicine for centuries. It has low solubility in aqueous solution and yields low serum levels following oral administration. In the setting of inflammatory bowel disease where the required site of action is the bowel, systemic absorption may be less relevant. Curcumin and its reduced metabolites undergo conjugation in the liver. Curcumin has a half life of 6-7 hours. It has been found to be safe at oral doses of 2 gm and 3 gm a day in patients with ulcerative colitis, for up to 1 year. In a dose titration study conducted in children with inflammatory bowel disease 2 gm twice daily of curcumin was well tolerated

Active Comparator: Artesunate and Placebo C
Artesunate 200 mg PO once a day x 2 weeks. Placebo C x 13 weeks.
Drug: Artesunate
Artesunate is approved for the treatment of malaria and is on the World Health Organization list of Essential Medicines. Artesunate has a hemisuccinate group which confers substantial water-solubility and high oral bioavailability and therefore a convenient oral route of administration. Artesunate has a good safety and tolerability profile, having been used to treat millions of adults and children globally.

Drug: Placebo C
Curcumin looking placebo

Active Comparator: Curcumin and Placebo A
Placebo A x 2 weeks. Curcumin 2 gm PO once a day x 13 weeks.
Drug: Curcumin
Curcumin has been used in Indian cuisine and traditional medicine for centuries. It has low solubility in aqueous solution and yields low serum levels following oral administration. In the setting of inflammatory bowel disease where the required site of action is the bowel, systemic absorption may be less relevant. Curcumin and its reduced metabolites undergo conjugation in the liver. Curcumin has a half life of 6-7 hours. It has been found to be safe at oral doses of 2 gm and 3 gm a day in patients with ulcerative colitis, for up to 1 year. In a dose titration study conducted in children with inflammatory bowel disease 2 gm twice daily of curcumin was well tolerated

Drug: Placebo A
Artesunate looking placebo

Placebo Comparator: Placebo A and Placebo C
Placebo A x 2 weeks. Placebo C x 13 weeks.
Drug: Placebo A
Artesunate looking placebo

Drug: Placebo C
Curcumin looking placebo




Primary Outcome Measures :
  1. Remission of disease [ Time Frame: Baseline to 6 months ]
    Remission of disease as defined by a Crohn's Disease Activity Index (CDAI < 150). The change in response will be studied by studying the change in CDAI after 1 week, 1 month, 3 months and 6 months


Secondary Outcome Measures :
  1. Effect of artesunate and curcumin on azathioprine metabolites [ Time Frame: Baseline to 1 week ]
    Change from baseline, in levels of thiopurine metabolites 6-Thioguanine/6-methylmercaptopurine after 1 week

  2. Change in tumor necrosis factor-alpha [ Time Frame: baseline to 6 months ]
    Change in tumor necrosis factor-alpha after 1 week, 1 month, 3 months and six months

  3. Change in C-reactive protein [ Time Frame: baseline to 6 months ]
    Change in C-reactive protein after 1 week, 1 month, 3 months and six months

  4. Change in fecal calprotectin [ Time Frame: baseline to 6 months ]
    Change in fecal calprotectin after 1 week, 1 month, 3 months and six months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713631


Contacts
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Contact: Uday C Ghoshal 2494405 ext 0522 udayghoshal@gmail.com
Contact: Devinder Kumar kumardkd@hotmail.com

Locations
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India
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, India, 226014
Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
St George's University of London, London, UK
Investigators
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Principal Investigator: Uday C Ghoshal Medical council of India, Association of Indian Universities
Publications:
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Responsible Party: Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT04713631    
Other Study ID Numbers: 2020-37-EMP-114
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will be conducted in the Department of Gastroenterology in collaboration Prof. Devinder Kumar,GastroIntestinal Surgery at St George's, University of London Kingston upon Thames, United Kingdom and in inter-departmental collaborations with the department of Microbiology having patients with clinical suspicion with Crohn's disease and facility for laboratory works.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Crohn's Disease Activity Index (CDAI)
Artesunate
Curcumin
Azathioprine
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Artesunate
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics