Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02683733
• 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 Mild to Moderate Ulcerative Colitis
• Scientific title: The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
• Date of first enrolment: February 2016
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02683733
• 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

• Name: Rupa Banerjee, MD, DM
• Affiliation: Asian Institutes of Gastroenterology

• Name: Rupa Banerjee, MD, DM

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have mild to moderate ulcerative colitis, with a current Partial Mayo
Index greater than or equal to 2 and less than or equal to 6

- Age 18 years and above

- Male or female

- Patients who have given consent and area able to follow the treatment given

- Patients who are able to record their responses in survey form at regular follow-up
visits

Exclusion Criteria:

- Patients who are in remission from ulcerative colitis, or who have a Partial Mayo
Index Score of 0 or 1

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

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

- Patients who have severe ulcerative colitis, or who have a Partial Mayo Index Score
of 7 or above

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

- Patients who are unable to 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 any biliary dysfunction

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

- Patients who currently have an ongoing severe infection/sepsis

- 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-Aminosalicylic acid

Primary Outcome(s)

Time to induction of endoscopic remission in the treatment arm compared with time to induction of endoscopic remission in control arm [Time Frame: 1 year]

Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in 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 control arm [Time Frame: 1 year]

Secondary ID(s)

AIGINDIACurcumin1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors