Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

This study is currently recruiting participants.
Verified April 2013 by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01735097
First received: November 15, 2012
Last updated: April 24, 2013
Last verified: April 2013

November 15, 2012
April 24, 2013
January 2013
October 2013   (final data collection date for primary outcome measure)
Clinical improvement of signs and symptoms of palmer arsenical keratosis [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01735097 on ClinicalTrials.gov Archive Site
  • Arsenic level in nails [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]
    Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.
  • Estimation of serum vitamin E levels [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]
    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.
  • Estimation of serum total cholesterol levels [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]
    To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.
  • Liver function [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: Yes ]
    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.
  • Renal function [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
A Double-blind, Randomized, Placebo-controlled Trial 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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arsenical Keratosis
  • Dietary Supplement: Vitamin E
    Vitamin E (200 mg, soft capsule)
  • Dietary Supplement: Nigella sativa
    Nigella sativa (200 mg, soft capsule)
  • Dietary Supplement: Placebo
    Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)
  • Experimental: Arsenical keratosis (Study)
    Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks
    Interventions:
    • Dietary Supplement: Vitamin E
    • Dietary Supplement: Nigella sativa
  • Active Comparator: Arsenical keratosis (Control)
    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
    Interventions:
    • Dietary Supplement: Vitamin E
    • Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Mir Misbahuddin, MBBS, PhD 8801849396067 misbah@bdjpharmacol.com
Contact: Tahmina Bashar, MBBS, MPhil 8801720096868 tahminabashar6@gmail.com
Bangladesh
 
NCT01735097
BSMMU-002-CT
No
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Not Provided
Principal Investigator: Mir Misbahuddin, MBBS, PhD BSMMU
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP