A study to assess the efficacy of methotrexate with metformin in the treatment of chronic plaque psoriasis with metabolic syndrome

A prospective randomized control study to assess the efficacy of methotrexate monotherapy versus methotrexate with metformin in chronic plaque psoriasis with metabolic syndrome - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072788

Enrollment

Registered

2024-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: L400- Psoriasis vulgaris

Interventions

Intervention1: Methotrexate with metformin: Methotrexate 15mg/week oral with metformin 1g/day oral in divided doses for 16 weeks Control Intervention1: Methotrexate: Methotrexate 15mg/week oral for 16

Eligibility

Inclusion criteria

Inclusion criteria: moderate to severe chronic plaque psoriasis with PASI more than or equal to 5 with metabolic syndrome, patients of either sex aged 18-65 years, patients who are willing to participate in the study, patients who are willing to take photographs of skin lesions

Exclusion criteria

Exclusion criteria: severe types such as erythrodermic , guttate , pustular psoriasis and psoriatic arthritis , liver disease , cardiac disease with history of CCF , renal failure , pregnancy and lactation , patients with active and latent infections - tuberculosis , HIV ,syphilis , hepatitis , known contraindication to methotrexate and metformin

Design outcomes

Primary

Measure	Time frame
For Psoriasis assesed by PASI score . Improvement in skin lesions will be noted using serial photographs taken . For Metabolic Syndrome assessed by parameters like FBS ,PPBS ,BP ,Waist circumference and Fasting lipid profileTimepoint: Every 4 weeks till the end of study which is 16 weeks and during follow up period of 12 weeks	—

Secondary

Measure	Time frame
Subjective satisfaction will be assessed by Dermatology Life Quality Index questionnaire at the end of studyTimepoint: After 16 weeks at the end of the study	—

Countries

India

Contacts

Public ContactDr Vijayabhaskar C

Government stanley medical college and hospital , chennai

buskibuski@gmail.com9940429206

Outcome results

None listed

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