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A clinical trial to study the effects of two drugs, mesalamine and prednisolone in patients with ulcerative colitis

Randomized controlled trial studying the mucosal healing achieved at 6 weeks when comparing mesalamine and corticosteroids in ulcerative colitis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/11/005177
Enrollment
50
Registered
2014-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Ulcerative Colitis

Interventions

Intervention1: Mesalamine: 3.2-4.8g OD for 6 weeks Intervention2: Prednisolone: Corticosteroid known to be effective in inducing remission in ulcerative colitis Control Intervention1: Prednisolone: 40

Sponsors

Department of Gastroenterology PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Moderately active ulcerative colitis, Patients not receiving any treatment, or left treatment for more than one month

Exclusion criteria

Exclusion criteria: patients not giving consent, severe disease requiring intravenous drugs and/or hospitalization

Design outcomes

Primary

MeasureTime frame
Mucosal healing defined as absence of friability, blood, erosions and ulcers in all visualized segments of the gut mucosa.Timepoint: at 6 weeks—

Secondary

MeasureTime frame
Clinical remissionTimepoint: 6 weeks—

Countries

India

Contacts

Public ContactAmit Sharma

PGIMER, Chandigarh

dr_kochhar@hotmail.com9815699565

Outcome results

None listed

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