Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status: Completed

Conditions: Arsenical Keratosis

Treatments: Dietary Supplement: Nigella sativa; Dietary Supplement: Vitamin E; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01735097

BSMMU-002-CT

Details and patient eligibility

About

Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Arsenical keratosis (Study)

Experimental group

Description:

Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks

Treatment:

Dietary Supplement: Nigella sativa

Dietary Supplement: Vitamin E

Arsenical keratosis (Control)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Vitamin E