Chronic Arsenic Poisoning
Conditions
Brief summary
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
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.
Interventions
DRUGNeem plus propylene glycol plus salicylic acid
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
DRUGSalicylic acid
salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in palmer arsenical keratosis | 0 weeks (baseline), 12 weeks (end) | Size of keratotic lesion will be decreased |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in arsenic level in nail | 0 weeks (baseline), 12 weeks (end) | Arsenic level in nail will be decreased |
Countries
Bangladesh
Outcome results
None listed