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

18 Years
60 Years
Open (Enrolling)
Arsenical Keratosis

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Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Clinical improvement of signs and symptoms of palmer arsenical keratosis

Outcome Description:

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.

Outcome Time Frame:

up to 12 weeks

Safety Issue:


Principal Investigator

Mir Misbahuddin, MBBS, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Bangladesh: Ethical Review Committee

Study ID:




Start Date:

January 2013

Completion Date:

November 2013

Related Keywords:

  • Arsenical Keratosis
  • Arsenic
  • Keratosis
  • Nigella sativa
  • Palm
  • Vitamin E
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma