Clinical trial NCT01735097: Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
Official title: A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arsenical Keratosis
Keywords: Arsenic
Keratosis
Nigella sativa
Palm
Vitamin E
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Clinical improvement of signs and symptoms of palmer arsenical keratosis
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Arsenic level in nails
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Estimation of serum vitamin E levels
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Estimation of serum total cholesterol levels
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Liver function
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Renal function
timeFrame: 0 week (baseline), 12 weeks (end)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Mir Misbahuddin, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: