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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248792
Recruitment Status : Unknown
Verified September 2014 by C V Krishna, Narayana Medical College & Hospital.
Recruitment status was:  Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
C V Krishna, Narayana Medical College & Hospital

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.

Condition or disease Intervention/treatment Phase
Severe Plaque Type Psoriasis Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2013
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Group A
Methotrexate 10mg orally once weekly
Drug: Methotrexate
Active Comparator: Group B
Methotrexate 25mg orally once weekly
Drug: Methotrexate



Primary Outcome Measures :
  1. Improvement in health related quality of life [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. comparison of improvement in health related quality of life between Group A and Group B [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248792


Contacts
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Contact: C V Krishna, MD +91-0413-2655961 vijay_postgradmed@yahoo.com

Locations
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India
Narayana Med College and Hospital Recruiting
Nellore, AP, India, 524003
Contact: Avisa Rao, MD         
Sponsors and Collaborators
Narayana Medical College & Hospital
Investigators
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Principal Investigator: C V Krishna, MD Narayana Medical college and hospital

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Responsible Party: C V Krishna, Narayana Medical College & Hospital
ClinicalTrials.gov Identifier: NCT02248792    
Other Study ID Numbers: NMCHDer
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors