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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 March 2016
Main ID:  NCT02683759
Date of registration: 10/02/2016
Prospective Registration: No
Primary sponsor: Asian Institute of Gastroenterology, India
Public title: Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis
Scientific title: The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis
Date of first enrolment: February 2016
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02683759
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
India
Contacts
Name:     Rupa Banerjee, MD, DM
Address: 
Telephone:
Email:
Affiliation:  Asian Institute of Gastroenterology
Name:     Rupa Banerjee, MD, DM
Address: 
Telephone:
Email: dr_rupa_banerjee@hotmail.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have been in symptomatic remission from Ulcerative Colitis for at least
3 months. This is defined as a Partial Mayo Index Score of 0 or 1

- Age 18 years and above

- Male or female

- Patients who are able and willing to follow the treatment given and record responses
in survey form

Exclusion Criteria:

- Patients who are currently experiencing symptomatic flares of mild or moderate
ulcerative colitis, or have a partial mayo index score of 2 or greater

- Patients who have been taking azathioprine or mercaptopurine for <12 weeks for the
treatment of their ulcerative colitis

- Patients who are taking steroids, immunosuppressants, or biologic agents for the
treatment of their ulcerative colitis

- Patients who have severe ulcerative colitis

- Patients who are noncompliant with medication or regular follow up visits

- Patients who are unable or unwilling to record their responses in survey form

- Patients with comorbid illnesses, including: Diabetes Mellitus, Stage III or above
Congestive Heart Failure, chronic pancreatitis, severe liver or renal disease

- Patients who have current gallstones or biliary dysfunction

- Patients with anemia (Hemoglobin <10), thrombocytopenia, abnormal lymphocyte counts,
or coagulation abnormalities

- Patients with current sepsis or current ongoing infection, including C. difficile
colitis or enteritis

- Patients with a history of malignancy

- Patients who are currently pregnant or nursing

- Patients who are current smokers



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Intervention(s)
Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule
Drug: 5-Aminosalicyclic acid
Primary Outcome(s)
Percentage of patients who remained in endoscopic remission in the treatment arm compared with percentage of patients who remained in endoscopic remission in the control arm [Time Frame: 1 year]
Percentage of patients who remained in clinical remission in the treatment arm compared with percentage of patients who remained in clinical remission in the control arm [Time Frame: 1 year]
Secondary Outcome(s)
Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm [Time Frame: 1 year]
Secondary ID(s)
AIGINDIACurcumin2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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