Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.

Overview

Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.

Full Title of Study: “Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2015

Interventions

  • Drug: Methotrexate

Arms, Groups and Cohorts

  • Experimental: Group A
    • Methotrexate 10mg orally once weekly
  • Active Comparator: Group B
    • Methotrexate 25mg orally once weekly

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in health related quality of life
    • Time Frame: 12 weeks

Secondary Measures

  • comparison of improvement in health related quality of life between Group A and Group B
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA >10% or PASI >12) - Exclusion Criteria:

Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Narayana Medical College & Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: C V Krishna, C V Krishna – Narayana Medical College & Hospital
  • Overall Official(s)
    • C V Krishna, MD, Principal Investigator, Narayana Medical college and hospital
  • Overall Contact(s)
    • C V Krishna, MD, +91-0413-2655961, vijay_postgradmed@yahoo.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.