Rutin Therapy Role in Reducing Ulcerative Colitis Severity

NCT ID: NCT07147842

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-05-20

Brief Summary

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Ulcerative colitis (UC) is an inflammatory bowel disease characterized by oxidative stress and recurring inflammation in the colon. The condition can become chronic, spread, and lead to other complications.

A key player in the inflammation process is the NLRP3 inflammasome. This inflammasome's expression is heightened and activated by reactive oxygen species (ROS). Its activity is influenced by various factors, including the ubiquitin system, ion channels, and gut microbiota.

Rutin, a compound found in many fruits and vegetables, has been shown to have properties that help scavenge free radicals.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Ulcerative Colitis-A (UC-A)

Patients diagnosed with active Ulcerative Colitis were assigned as group UC-A

Group Type ACTIVE_COMPARATOR

Rutin 500 MG

Intervention Type DRUG

Rutin 500 mg capsules twice daily for 30 days

fecal calprotectin

Intervention Type DIAGNOSTIC_TEST

Fecal calprotectin level was measured using an ELISA kit .

Ulcerative Colitis-B (UC-B)

Patients diagnosed with remission Ulcerative Colitis were assigned as control group UC-B

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Tablets

fecal calprotectin

Intervention Type DIAGNOSTIC_TEST

Fecal calprotectin level was measured using an ELISA kit .

Healthy Group (C)

Healthy volunteers provided samples as negative controls; and was assigned as group C

Group Type ACTIVE_COMPARATOR

fecal calprotectin

Intervention Type DIAGNOSTIC_TEST

Fecal calprotectin level was measured using an ELISA kit .

Interventions

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Rutin 500 MG

Rutin 500 mg capsules twice daily for 30 days

Intervention Type DRUG

Placebo

Placebo Tablets

Intervention Type OTHER

fecal calprotectin

Fecal calprotectin level was measured using an ELISA kit .

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients presenting with symptoms suggestive of IBD;
* Patients with positive microscopic mucosal changes consistent with UC.

Exclusion Criteria

* Patients with the presence of recurrent ulceration after surgical treatment, malignancy, or autoimmune disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Afnan El Gindy

Lecturer of Physiology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha University

Banhā, El Qalyoubia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC 3.7.2025

Identifier Type: -

Identifier Source: org_study_id

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