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Completed

NCT Number: NCT01735097

Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

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

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Key information

Conditions

Arsenical Keratosis Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Dietary Supplement

Vitamin E (200 mg, soft capsule)

Nigella sativa

Dietary Supplement

Nigella sativa (200 mg, soft capsule)

Placebo

Dietary Supplement

Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

Primary outcomes

  1. Clinical improvement of signs and symptoms of palmer arsenical keratosis

    Time frame: 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 outcomes

  1. Arsenic level in nails

    Time frame: 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.

  2. Estimation of serum vitamin E levels

    Time frame: 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.

  3. Estimation of serum total cholesterol levels

    Time frame: 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.

  4. Liver function

    Time frame: 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.

  5. Renal function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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