Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

May 2, 2014 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 week (baseline), 12 weeks (end)
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.
0 week (baseline), 12 weeks (end)
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.
0 week (baseline), 12 weeks (end)
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.
0 week (baseline), 12 weeks (end)
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.
0 week (baseline), 12 weeks (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

November 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU-002-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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