Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis

Study Overview
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Brief Summary
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This study is designed to find out the effectiveness of combination of ethanol extract of neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis.

Detailed Description
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Arsenic, a non-essential trace element, is a major water pollutant in Bangladesh. Arsenical keratosis, which occurs in the palm and sole, is a common symptom of arsenicosis. The objective of this study is to find the effectiveness of combination of topical administration of the ethanol extract of leaf of neem (Azadirachta indica), propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis. On the basis of inclusion and exclusion criteria, 30 patients of moderate palmar arsenical keratosis will be recruited from an arsenic affected area. They will be divided into two groups: study group and placebo comparator group. Each group consisting of 15 members. Study group will be given combination of ethanol extract of leaf of neem, propylene glycol (40%) and salicylic acid (10%) to apply on palm overnight once daily for 12 weeks. On the other hand placebo comparator group will be given salicylic (10%) acid to apply on palm overnight once daily for 12 weeks. Water and nail samples will be collected before starting recruitment to confirm arsenicosis. After conclusive recruitment of the subjects the objective, nature, purpose and potential risks and benefits of all procedures of the study will be explained in details to the patients and informed written consent will be taken from them. Detail history, clinical examination and photograph (palm) will also be collected. Clinical improvement will be assessed by measuring palmar nodular size on both hands, before starting treatment and after 12 weeks completion of treatment and perception of patients about their improvement. The study will explore the effectiveness of topical use of combination of ethanol extract of neem, propylene glycol and salicylic acid for the treatment of palmar arsenical keratosis.

Official Title
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Randomized, Single Blind, Placebo Controlled Clinical Trial to See the Effect of Combination of Neem, Propylene Glycol and Salicylic Acid in the Treatment of Arsenical Palmar Keratosis

Conditions
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Chronic Arsenic Poisoning

Intervention / Treatment
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* Drug: Neem plus propylene glycol plus salicylic acid
* Drug: Salicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-60 years Palmar arsenical keratosis Drinking arsenic contaminated water (>50 µg/L) for more than six months Patient voluntarily agree to participate Exclusion Criteria: Pregnancy and lactating mother Skin lesion :Psoriasis and eczema Bowen's disease Any kind of systemic disease, inflammatory disease and infectious condition that affect skin (Diabetes mellitus, Rheumatoid arthritis, Systemic lupus erythematosus , Hepatitis and Tuberculosis) Hypersensitivity to any drug Patient who received treatment within last three months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with 3 drugs<br>Neem plus propylene glycol plus salicylic acid: Neem extract, propylene glycol (40%) and salicylic acid (10%) once daily on palm for 12 weeks | Drug: Neem plus propylene glycol plus salicylic acid<br>* Leaf extract of neem plus propylene glycol (40%) plus salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks<br>* Other names: In house prepared;|
| Active Comparator: Patients treated with 1 drug<br>Salicylic acid once daily on palm for 12 weeks | Drug: Salicylic acid<br>* salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks<br>* Other names: In house prepared;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in palmer arsenical keratosis | Size of keratotic lesion will be decreased | 0 weeks (baseline), 12 weeks (end) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in arsenic level in nail | Arsenic level in nail will be decreased | 0 weeks (baseline), 12 weeks (end) |