Back to resultsQuality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
Primary Purpose
Severe Plaque Type Psoriasis
Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Severe Plaque Type Psoriasis
Eligibility Criteria
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
-
Sites / Locations
- Narayana Med College and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Methotrexate 10mg orally once weekly
Methotrexate 25mg orally once weekly
Outcomes
Primary Outcome Measures
Improvement in health related quality of life
Secondary Outcome Measures
comparison of improvement in health related quality of life between Group A and Group B
Full Information
NCT ID
NCT02248792
First Posted
September 22, 2014
Last Updated
September 22, 2014
Sponsor
Narayana Medical College & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02248792
Brief Title
Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
Official Title
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
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Narayana Medical College & Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Plaque Type Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Methotrexate 10mg orally once weekly
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Methotrexate 25mg orally once weekly
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Primary Outcome Measure Information:
Title
Improvement in health related quality of life
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
comparison of improvement in health related quality of life between Group A and Group B
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C V Krishna, MD
Phone
+91-0413-2655961
Email
vijay_postgradmed@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C V Krishna, MD
Organizational Affiliation
Narayana Medical college and hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Narayana Med College and Hospital
City
Nellore
State/Province
AP
ZIP/Postal Code
524003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avisa Rao, MD
12. IPD Sharing Statement
Learn more about this trial
Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
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