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

Ulcerative Colitis Clinical Trial

Official title:

The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683733
• Other study ID #: AIGINDIACurcumin1
• Status: Recruiting
• Phase: Phase 3
• First received: February 10, 2016
• Last updated: February 20, 2016
• Start date: February 2016

Study information

• Verified date: February 2016
• Source: Asian Institute of Gastroenterology, India
• Contact: Rupa Banerjee, MD, DM
• Email: dr_rupa_banerjee[@]hotmail.com
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of treatment options are directed at attempting to control the chronic inflammation and prolonging remission of clinical symptoms. Several studies have proven that curcumin has well-established anti-inflammatory properties. However, curcumin has poor bioavailability and prior studies have needed to use high concentrations in order to study the efficacy of the product. The investigators propose that a bio-enhanced preparation of curcumin will require a lower dosage to reach and affect its target tissue and will subsequently produce less adverse side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Bio-enhanced Curcumin Soft Gelatin Capsule
Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)

Drug:
• 5-Aminosalicylic acid
Dosage is as instructed by patient's physician

Locations

Country	Name	City	State
India	Asian Institutes of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in control arm	Clinical remission is recorded by a Partial Mayo Index score of 0-1	1 year	No
Primary	Time to induction of endoscopic remission in the treatment arm compared with time to induction of endoscopic remission in control arm	Endoscopic remission is defined as endoscopic mucosal healing, is recorded by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of <3	1 year	No
Secondary	Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the control arm		1 year	No