Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial
The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.
Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Changes in palmer arsenical keratosis
Size and number of keratotic lesions will be reduced. These will be expressed in score.
Time frame: 0 week (baseline), 12 weeks (end)
Changes in arsenic level in nail
Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.
Time frame: 0 week (baseline), 12 weeks (end)
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