Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Study Overview
=================
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

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Conditions
-----------------
Arsenical Keratosis

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin E
* Dietary Supplement: Nigella sativa
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arsenical keratosis (Study)<br>Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks | Dietary Supplement: Vitamin E<br>* Vitamin E (200 mg, soft capsule)<br>Dietary Supplement: Nigella sativa<br>* Nigella sativa (200 mg, soft capsule)<br>|
| Active Comparator: Arsenical keratosis (Control)<br>Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks | Dietary Supplement: Vitamin E<br>* Vitamin E (200 mg, soft capsule)<br>Dietary Supplement: Placebo<br>* Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of signs and symptoms of palmer arsenical keratosis | 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. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arsenic level in nails | Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment. | 0 week (baseline), 12 weeks (end) | 
| Estimation of serum vitamin E levels | 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. | 0 week (baseline), 12 weeks (end) | 
| Estimation of serum total cholesterol levels | To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method. | 0 week (baseline), 12 weeks (end) | 
| Liver function | 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. | 0 week (baseline), 12 weeks (end) | 
| Renal function | 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. | 0 week (baseline), 12 weeks (end) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arsenic, Keratosis, Nigella sativa, Palm, Vitamin E