Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Changes in palmer arsenical keratosis
Size and number of keratotic lesions will be reduced. These will be expressed in score.
0 week (baseline), 12 weeks (end)
No
Mir Misbahuddin, MBBS, PhD
Principal Investigator
BSMMU
Bangladesh: Ethical Review Committee
BSMMU-003-CT
NCT01731756
January 2013
March 2014
Name | Location |
---|