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Comparison of efficacy and safety of oral vs subcutaneous methotrexate in psoriasis

Not Applicable
Conditions
Health Condition 1: null- Psoriasis Vulgaris
Registration Number
CTRI/2018/01/011373
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1)Patients aged more than 18 years with clinical diagnosis of plaque psoriasis

2)Patients with body surface area involvement > 10 %, PASI >10,

Exclusion Criteria

1)Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3

2)Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or γ glutamyl transferase [GGT]) to more than twice the upper limit of normal.

3)Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake .

4)Use of other hepatotoxic drugs by the patient

5)Positive hepatitis B, hepatitis C or HIV serology

6)Pulmonary or extra-pulmonary active tuberculosis

7)Deranged renal function test.

8)Pregnancy or lactation or if patient is planning to conceive during the treatment period.

9)Patient on other immunosuppressive drugs

10)Recent live vaccination

11)Unreliable patient

12)Patients unwilling for monthly follow-ups.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Difference in the percentage of patients who achieved PASI 90 (90 % reduction in psoriasis area severity score (PASI) compared to baseline) in both the groupsTimepoint: 0 Weeks and 12 Weeks
Secondary Outcome Measures
NameTimeMethod
1.Improvement in DLQI (dermatology life quality index). <br/ ><br>2.Relapse free period after stopping treatment. <br/ ><br>3.Adverse events if any. <br/ ><br>Timepoint: baseline and 12 weeks <br/ ><br>Follow up after treatment 6 months
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