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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Active Comparator | Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take Bio-enhanced curcumin twice daily after meals as per the following regimen: Starting dose: 50 mg BID of Bio-enhanced Curcumin Soft Gelatin Capsule Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug |
|
| Control Arm | Placebo Comparator | Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-enhanced Curcumin Soft Gelatin Capsule | Dietary Supplement | Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the control arm | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupa Banerjee, MD, DM | Contact | dr_rupa_banerjee@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rupa Banerjee, MD, DM | Asian Institutes of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institutes of Gastroenterology | Recruiting | Hyderabad | Telangana | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32889959 | Derived | Banerjee R, Pal P, Penmetsa A, Kathi P, Girish G, Goren I, Reddy DN. Novel Bioenhanced Curcumin With Mesalamine for Induction of Clinical and Endoscopic Remission in Mild-to-Moderate Ulcerative Colitis: A Randomized Double-Blind Placebo-controlled Pilot Study. J Clin Gastroenterol. 2021 Sep 1;55(8):702-708. doi: 10.1097/MCG.0000000000001416. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| 5-Aminosalicylic acid | Drug | Dosage is as instructed by patient's physician |
|
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |