Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Study Overview
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Brief Summary
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Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

Detailed Description
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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.

Official Title
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Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial

Conditions
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Arsenical Keratosis

Intervention / Treatment
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* Other: Leaf extract of A. indica
* Drug: Salicylic Acid (6%)
* Other: Petroleum jelly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Palmer arsenical keratosis Drinking arsenic contaminated water (>50 ppb) for more than six months Patient voluntarily agree to participate Exclusion Criteria: Pregnancy Lactating mother Diabetes mellitus Rheumatoid arthritis Systemic lupus erythematosus Psoriasis Bowen's disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palmer arsenical keratosis (study)<br>Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks | Other: Leaf extract of A. indica<br>* Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.<br>Drug: Salicylic Acid (6%)<br>* Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.<br>Other: Petroleum jelly<br>* Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.<br>|
| Placebo Comparator: Palmer arsenical keratosis (control)<br>Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks | Drug: Salicylic Acid (6%)<br>* Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.<br>Other: Petroleum jelly<br>* Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 week (baseline), 12 weeks (end) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palm, Arsenic, Keratosis, Salicylic acid, Azadirachta indica, Neem