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Investigating the effect of pomegranate peel supplement in ulcerative colitis

The effect of pomegranate peel supplementation on the serum levels of IL-6, IL-10, disease activity index and quality of life in patients with mild to moderate ulcerative colitis: a double-blind clinical trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091114002709N60
Enrollment
80
Registered
2023-07-01
Start date
2023-06-25
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease, ulcerative colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: The group receiving the supplement of 500 mg of dry pomegranate peel extract for eight weeks. In this study, the supplements of Adib Elixir herbal products company

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Shidfar

Iran University of Medical Sciences

shidfar.f@iums.ac.ir+98 21 8862 2755

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026