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Investigating the effect of pomegranate peel supplement in ulcerative colitis

Phase 2
Recruiting
Conditions
Inflammatory bowel disease, ulcerative colitis.
Ulcerative colitis
Registration Number
IRCT20091114002709N60
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

1. Patient consent to participate in the study
2. Aged 18 years or older (age = 18 years)
3. BMI above 18.5 and less than 30 kg/m2 (30 = BMI = 18.5)
4. Diagnosis of ulcerative colitis by a specialist
5. People with mild to moderate ulcerative colitis according to specialist diagnosis and the Partial Mayo scoring index
6. Users of oral drugs of the 5-aminosalicylic acid group (pentasa, mesalazine or asacol, sulfasalazine) as well as immunomodulatory drugs (azathioprine, methotrexate, prograf, selpest or 6-mercaptopurine).

Exclusion Criteria

1. Changing the type and dosage of the drug used during the last month
2. Pregnant or lactating women
3. Suffering from other diseases, including digestive diseases, autoimmune diseases, cancer, inflammatory and infectious diseases
4. Use of multivitamin-mineral, omega-3, polyphenolic, antioxidants, and herbal supplements during the past month (except for commonly prescribed supplements in ulcerative colitis)
5. Use of corticosteroids, NSAIDs (profen, aspirin and diclofenac), and anti-TNF drugs (Cinnora or Adalimumab, Infliximab or Remicade)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Interleukin 6. Timepoint: ??At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Blood test.;Interleukin 10. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Blood test.;Disease activity index. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Disease activity index questionnaire.;Quality of life. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: IBD quality of life questionnaire.
Secondary Outcome Measures
NameTimeMethod
Blood pressure. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Upper arm blood pressure digital monitor.
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