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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
History of Changes
  Purpose

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


Condition Intervention
Arsenical Keratosis
 Dietary Supplement: Vitamin E
Dietary Supplement: Nigella sativa
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Resource links provided by NLM:

MedlinePlus related topics: Arsenic Vitamin E
U.S. FDA Resources

Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenical keratosis (Study)
Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks
 Dietary Supplement: Vitamin E
Vitamin E (200 mg, soft capsule)
Dietary Supplement: Nigella sativa
Nigella sativa (200 mg, soft capsule)
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
 Dietary Supplement: Vitamin E
Vitamin E (200 mg, soft capsule)
Dietary Supplement: Placebo
Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735097

Contacts
Contact: Mir Misbahuddin, MBBS, PhD 8801849396067 misbah@bdjpharmacol.com
Contact: Tahmina Bashar, MBBS, MPhil 8801720096868 tahminabashar6@gmail.com

Locations
Bangladesh
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Bangladesh
Contact: Mir Misbahuddin, MBBS, PhD     8801849396067     misbah@bdjpharmacol.com    
Contact: Tahmina Bashar, MBBS, MPhil     8801720096868     tahminabashar6@gmail.com    
Principal Investigator: Mir Misbahuddin, MBBS, PhD            
Sub-Investigator: Tahmina Bashar, MBBS, MPhil            
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
Principal Investigator: Mir Misbahuddin, MBBS, PhD BSMMU
  More Information

No publications provided

Responsible Party: Prof. Mir Misbahuddin, Prof. and Chairman, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01735097     History of Changes
Other Study ID Numbers: BSMMU-002-CT
Study First Received: November 15, 2012
Last Updated: April 24, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Arsenic
Keratosis
Nigella sativa
Palm
Vitamin E

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Ichthyosis
Keratoacanthoma
Skin Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Vitamin E
 Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013