Action of Curcuma Longa and Piperine on the oxidative and inflammatory profile of patients with Inflammatory Bowel Disease: a randomized, double-blind, placebo-controlled study
Not Applicable
Terminated
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- RBR-89q4ydz
- Lead Sponsor
- niversidade Federal de Alagoas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Patients diagnosed with IBD (Crohn's Disease, Ulcerative Colitis or Unclassified Colitis) of mild to moderate intensity; age equal to or greater than 18 years and up to 80 years; Patients using conventional drug therapy for IBD (aminosalicylates, immunosuppressants, biological); Function preserved kidney and liver
Exclusion Criteria
Pregnancy; Change or withdrawal of dosage/conventional medication for IBD; HIV positive patients and compromised renal and hepatic function; Patients who made inadequate use of supplementation (did not ingest the recommended daily dose)
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected Outcome 1 - It is expected to find improved antioxidant activity (reduction of lipid peroxidation - malonaldehyde levels (MDA) and oxidized glutathione (GSSG) - increased antioxidant activity - superoxide dismutase (SOD), reduced glutathione (GSH), and reduced inflammatory activity (tumor necrosis factor alpha (TNF?) and interleukins (IL));Outcome found 1 - It was noticed that there were no changes in the inflammatory profile (fecal calprotectin, TNFa and IL) after supplementation with curcumin and curcumin+piperine. Regarding oxidative stress, the group supplemented with curcumin+piperine had an increase in SOD activity (p<0.05) compared to the placebo group.
- Secondary Outcome Measures
Name Time Method Expected outcome 2 - It was expected to find improvement in gastrointestinal complaints, such as nausea, vomiting, diarrhea, constipation, etc.