Suspended

The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis

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What is being tested

Bio-enhanced Curcumin Soft Gelatin Capsule

+ 5-Aminosalicyclic acid

Dietary SupplementDrug
Who is being recruted

Colitis+5

+ Colitis, Ulcerative

+ Colonic Diseases

From 18 to 70 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: February 2016
See protocol details

Summary

Principal SponsorAsian Institute of Gastroenterology, India
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleThe Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis
NCT02683759
Principal SponsorAsian Institute of Gastroenterology, India
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColitis, UlcerativeColonic DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

4 inclusion criteria required to participate
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
13 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Patients will receive 5-Aminosalicyclic acid as per their current treatment regimen and will also take Bio-enhanced curcumin twice daily after meals as per the following regimen:

Group II

Placebo
Patients will receive 5-Aminosalicyclic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Asian Institutes of Gastroenterology

Hyderabad, IndiaOpen Asian Institutes of Gastroenterology in Google Maps
SuspendedOne Study Center