The effect of grape seed extract in ulcerative colitis

The effect of grape seed extract on the expression of genes mediating immunity, inflammation, disease severity and quality of life in patients with ulcerative colitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120415009472N28

Enrollment

Registered

2023-09-05

Start date

2023-10-07

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Patients with ulcerative colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: Patients will receive 600 mg/day (two tablets of 300 mg) of grape seed extract, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 w

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: BMI of patients between 18.5-35 kg/m2 Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist based on patient tests, patient symptoms (disease severity questionnaire)and colonoscopy. Patients using one of the drug groups (5-aminosalicylic acid (Petasa, Mesalazine or Asacol).

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding Taking anticoagulants such as warfarin or heparin Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases.

Design outcomes

Primary

Measure	Time frame
T-bet gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;GATA3 gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;ROR-?tgene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;FOXp3 gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;Serum concentration of hs-CRP. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Eliza.;Serum concentration of IL-17. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Eliza.;ESR. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: westergren.;Disease Severity(SCCAI-Q). Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Severity of Disease Questionnaire (SCCAI-Q).;Quality of Life(IBDQ-9). Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Quality of life questionnaire(IBDQ-9).;Total Antioxidant Capacity. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: TAC concentration in serum using an ELISA kit.;Malondialdehyde (MDA). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: MDA concentration in serum using an ELISA kit.;Superoxide dismutase (SOD). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: SOD concentration in serum using an ELISA kit.;Glutathione peroxidase (GPX). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: GPX concentration in serum using an ELISA kit.	—

Measure

Time frame

T-bet gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;GATA3 gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;ROR-?tgene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;FOXp3 gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR.;Serum concentration of hs-CRP. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Eliza.;Serum concentration of IL-17. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Eliza.;ESR. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: westergren.;Disease Severity(SCCAI-Q). Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Severity of Disease Questionnaire (SCCAI-Q).;Quality of Life(IBDQ-9). Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Quality of life questionnaire(IBDQ-9).;Total Antioxidant Capacity. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: TAC concentration in serum using an ELISA kit.;Malondialdehyde (MDA). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: MDA concentration in serum using an ELISA kit.;Superoxide dismutase (SOD). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: SOD concentration in serum using an ELISA kit.;Glutathione peroxidase (GPX). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: GPX concentration in serum using an ELISA kit.

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Secondary

Measure	Time frame
BMI. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Weight(kg)/ (height)m².	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nahid Aryaeian

Iran University of Medical Sciences

aryaeian.n@iums.ac.ir+98 21 8670 4734

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Sep 17, 2026