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Comparative assessment of effectiveness and safety of methotrexate, pioglitazone and their combination therapy in patients with moderate to severe chronic plaque psoriasis

Comparative clinical evaluation of efficacy and safety of methotrexate and Pioglitazone and their combination therapy in patients with moderate to severe chronic plaque-type psoriasis: a randomized, open labeled, active-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003904
Enrollment
90
Registered
2013-08-19
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- Plaque psoriasis

Interventions

Intervention1: Pioglatazone: Group B: Active treatment: Pioglitazone 15 mg tablets once daily orally for 12 weeks. Intervention2: Methotrexate + Pioglitazone combination.: Group C : Combination therap

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Age >= 18 years and less than 65 years. •New cases of Plaque psoriasis vulgaris >= 10% (apart from palmoplantar psoriasis which will be included). •Older cases of Plaque psoriasis vulgaris showing relapse after 4 wks of stopping the systemic treatment or patients who have left the treatment for 4 wks or more

Exclusion criteria

Exclusion criteria: •Age less than 18 years and more than 65 years •Mild psoriasis less than 10% body surface area •Erythrodermic, pustular psoriasis or guttate psoriasis. •Liver disease, cardiac disease (History of CHF), renal failure or any other major medical disorder detected by history. •Pregnant and lactating females. •Known contraindication to pioglitazone or methotrexate •Patient with active bladder cancer or with a prior history of bladder cancer.

Design outcomes

Primary

MeasureTime frame
Efficacy â?¢Treatment success detected as clinical improvement of skin condition â?¢% PASI improvement from baseline Timepoint: At 12 weeks

Secondary

MeasureTime frame
â?¢Treatment success detected as clinical improvement of skin condition â?¢% PASI improvement from baseline Timepoint: At 12 weeks

Countries

India

Contacts

Public ContactDr AFROZ ABIDI

Subharti Medical College, Meerut

afrozabidi@gmail.com8006336662

Outcome results

None listed

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