Ulcerative ColitisPhase 3NCT02683759
Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis
A Phase 3 study testing Bio-enhanced Curcumin Soft Gelatin Capsule and 5-Aminosalicyclic acid in people with Ulcerative Colitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Bio-enhanced Curcumin Soft Gelatin Capsule and 5-Aminosalicyclic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2016to Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institutes of Gastroenterology
Hyderabad, Telangana
Rupa Banerjee, MD, DM, dr_rupa_banerjee@hotmail.com
About this study
Official title: The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Bio-enhanced Curcumin Soft Gelatin Capsule, 5-Aminosalicyclic acid
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-enhanced Curcumin Soft Gelatin CapsuleDietary supplement
Also called Valdone
Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)
Starting dose: 50 mg BID of Bioenhanced Curcumin Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug
5-Aminosalicyclic acidDrug
Also called 5-ASA
Dosage is as instructed by patient's physician
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | 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: Receives: Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule; Drug: 5-Aminosalicyclic acid |
| Control Arm | Placebo comparator | Patients will receive 5-Aminosalicyclic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals Receives: Drug: 5-Aminosalicyclic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Clinical remission is recorded by a Partial Mayo Index score of 0-1
Measured: 1 year
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
Endoscopic remission is defined as endoscopic mucosal healing, is recorded by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of <3
Measured: 1 year
Secondary outcomes (1)
Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupa Banerjee, Asian Institute of Gastroenterology, India
- Investigators
- Rupa Banerjee, MD, DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683759
- Sponsor's protocol ID
- AIGINDIACurcumin2
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02683759
- Acronym / sponsor ID
- AIGINDIACurcumin2
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule, Drug: 5-Aminosalicyclic acidPatients 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: |
| Control Arm | Placebo comparator | Drug: 5-Aminosalicyclic acidPatients will receive 5-Aminosalicyclic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-enhanced Curcumin Soft Gelatin CapsuleAlso: ValdoneEach capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract) Starting dose: 50 mg BID of Bioenhanced Curcumin Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug | Dietary supplement | Treatment Arm |
| 5-Aminosalicyclic acidAlso: 5-ASADosage is as instructed by patient's physician | Drug | Control Arm, Treatment Arm |
Primary outcome
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
Clinical remission is recorded by a Partial Mayo Index score of 0-1
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
Endoscopic remission is defined as endoscopic mucosal healing, is recorded by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of <3
1 secondary outcome
Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupa Banerjee, MD, DM principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bio-enhanced Curcumin Soft Gelatin Capsule and 5-Aminosalicyclic acid in people with Ulcerative Colitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.