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CompletedNCT07147842Updated Aug 29, 2025

Rutin Therapy Role in Reducing Ulcerative Colitis Severity

An interventional study of Rutin 500 MG and Placebo in Ulcerative Colitis, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Benha University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2024, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ulcerative Colitis

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03

In context

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.

This study's enrollment of 60 is below the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with the presence of recurrent ulceration after surgical treatment, malignancy, or autoimmune disorders.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Ulcerative Colitis-A (UC-A)

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

    Drug: Rutin 500 MG · Diagnostic Test: fecal calprotectin

  • Active comparator
    Ulcerative Colitis-B (UC-B)

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

    Other: Placebo · Diagnostic Test: fecal calprotectin

  • Active comparator
    Healthy Group (C)

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

    Diagnostic Test: fecal calprotectin

Interventions

  • DrugRutin 500 MG

    Rutin 500 mg capsules twice daily for 30 days

  • OtherPlacebo

    Placebo Tablets

  • Diagnostic testfecal calprotectin

    Fecal calprotectin level was measured using an ELISA kit .

06

What researchers measure

Primary outcomes

  1. Success Rate of Treatment Regimens in improving the ulcerative colitis.

    The proportion of patients who achieved a Simple Clinical Colitis Activity Index (SCCAI) score of 5 or less at the end of the study, which reflects the effectiveness of the treatment.

    Time frame: 3~4 Months

07

Study locations

1 site
  • Benha University
    Banhā, El Qalyoubia 13511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07147842
Lead sponsor
Benha University
Responsible party
Afnan El Gindy (Lecturer of Physiology, Faculty of Medicine, Benha University) — Principal investigator
First posted
Aug 29, 2025
Start date
Nov 1, 2024
Primary completion
Jan 8, 2025
Completion
May 20, 2025
Last update
Aug 29, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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