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Comparison of efficacy and safety of azathioprine and methotrexate in patients of hand eczema.

Phase 4
Conditions
Health Condition 1: L308- Other specified dermatitis
Registration Number
CTRI/2019/01/017217
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients diagnosed as moderate to severe hand eczema (HECSI score >12).

Age >18 years.

Exclusion Criteria

1.Patients with hepatic/ renal disease/pulmonary fibrosis.

2.Severe anaemia, leucopenia or thrombocytopenia.

3.Active infectious disease or immune system deficiency including AIDS.

4.Pregnant or lactating women.

5.Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP > 1.5 times the upper limit of normal), viral hepatitis or cirrhosis.

6.H/o excessive alcohol consumption.

7.H/o intolerance/hypersensitivity to azathioprine and/or methotrexate.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare the clinical and functional outcome in each group, as assessed by HECSI and DLQI. <br/ ><br>To compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters.Timepoint: week 2, 4, 8 and 12 <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
ã??Evaluate the clinicodemographic factors predicting response in each group. <br/ ><br>To study the MOAHLFA index for demographic characteristics of patients.Timepoint: week 2,4,8 and 12
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