Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Study Overview
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Brief Summary
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Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.

Detailed Description
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Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment. Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.

Official Title
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Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Conditions
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Chronic Arsenic Poisoning

Intervention / Treatment
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* Dietary Supplement: Garlic oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Patients): history of taking arsenic contaminated water (>50 ppb) for more than 6 months patients having mild to moderate arsenical keratosis present on palm of the hand patients those voluntarily agree to participate Inclusion Criteria (Arsenic exposed controls): family member of the patient drinking arsenic contaminated water from the same source as patient those voluntarily agree to participate no sign/symptom of palmer keratosis Inclusion Criteria (Healthy volunteers): drinking arsenic safe water (<50 ppb) those voluntarily agree to participate Exclusion Criteria: pregnancy lactating mother patient receiving treatment of arsenicosis any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients of palmer arsenical keratosis<br>One soft capsule of garlic oil (10 mg) daily for 12 weeks | Dietary Supplement: Garlic oil<br>* Oral administration<br>|
| Active Comparator: Arsenic exposed controls<br>One soft capsule of garlic oil (10 mg) daily for 12 weeks | Dietary Supplement: Garlic oil<br>* Oral administration<br>|
| Active Comparator: Heathy volunteers<br>One soft capsule of garlic oil (10 mg) daily for 12 weeks | Dietary Supplement: Garlic oil<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical symptom of keratosis in palm |  | 0 week (baseline) to 12 weeks (end) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment |  | 0 week (baseline), 12 weeks (end) | 
| Adverse effects following treament |  | 0 week (baseline), 12 weeks (end) | 
| Change in the amount of arsenic in nail |  | 0 week (baseline), 20 weeks (end) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arsenic, Arsenicosis, Garlic oil, Keratosis