Arsenical Keratosis
Conditions
Keywords
Arsenic, Keratosis, Nigella sativa, Palm, Vitamin E
Brief summary
Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis
Detailed description
Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. Study population will be divided randomly into two equal groups: one group will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL) and urine (50 mL) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. Clinical examinations will be done at regular interval (two weeks). Clinical features and adverse effects will be recorded using a structured data collection sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of N. sativa on palmer arsenical keratosis patients
Interventions
DIETARY_SUPPLEMENTVitamin E
Vitamin E (200 mg, soft capsule)
DIETARY_SUPPLEMENTNigella sativa
Nigella sativa (200 mg, soft capsule)
DIETARY_SUPPLEMENTPlacebo
Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Moderate palmer arsenical keratosis * Patient drinking arsenic contaminated water (more than 0.05 mg/L) for more than six months * Subjects those voluntarily agree to participate
Exclusion criteria
* Patient received treatment of arsenicosis for the last three months * Pregnancy * Lactating mother * Eczema * Psoriasis * Contact dermatitis * Tuberculosis * Diabetes mellitus * Patients with hepatic and renal impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement of signs and symptoms of palmer arsenical keratosis | up to 12 weeks | Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor. Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arsenic level in nails | 0 week (baseline), 12 weeks (end) | Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment. |
| Estimation of serum vitamin E levels | 0 week (baseline), 12 weeks (end) | To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method. |
| Estimation of serum total cholesterol levels | 0 week (baseline), 12 weeks (end) | To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method. |
| Liver function | 0 week (baseline), 12 weeks (end) | To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method. |
| Renal function | 0 week (baseline), 12 weeks (end) | To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method. |
Countries
Bangladesh
Outcome results
None listed