Comparison between combined oral and topical 5-ASA versus topical 5-ASA on ulcerative proctitis.

Comparison between topical 5-ASA versus combined oral and topical 5-ASA for the treatment of ulcerative proctitis.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231029059892N1

Enrollment

Registered

2023-11-20

Start date

2023-11-21

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Ulcerative proctitis. Ulcerative (chronic) proctitis

Interventions

Intervention 1: Intervention group 1: Patients treated with Mesalazine suppositories at the rate of one gram per day for 6 months. Intervention 2: Intervention group 2: Patients treated with oral Mesa

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: All people who have been diagnosed with ulcerative proctitis through colonoscopy and histology during the years 1398-1402. Patients over 15 years old

Exclusion criteria

Exclusion criteria: Patients with salicylate allergy Active peptic disease A proven coagulation problem Pregnant and lactating women Significant liver and kidney disease

Design outcomes

Primary

Measure	Time frame
Severity of disease activity. Timepoint: Start of study and 3 and 6 months later. Method of measurement: Simple Clinical Colitis Activity Index (SCCAI) And Disease Activity Index (DAI).;Response to treatment. Timepoint: Start of study and 6 months later. Method of measurement: Colonoscopy and Biopsy.;Laboratory criteria. Timepoint: Start of study and 3 and 6 months later. Method of measurement: Blood test.	—

Measure

Time frame

Severity of disease activity. Timepoint: Start of study and 3 and 6 months later. Method of measurement: Simple Clinical Colitis Activity Index (SCCAI) And Disease Activity Index (DAI).;Response to treatment. Timepoint: Start of study and 6 months later. Method of measurement: Colonoscopy and Biopsy.;Laboratory criteria. Timepoint: Start of study and 3 and 6 months later. Method of measurement: Blood test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactEsmaeil Mirshafiee

Arak University of Medical Sciences

esmaeilmirshafiee@gmail.com+98 86 3836 0000

Outcome results

None listed

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