Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

NCT ID: NCT01735097

Last Updated: 2014-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Arsenical Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arsenical keratosis (Study)

Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks

Group Type EXPERIMENTAL

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

Vitamin E (200 mg, soft capsule)

Nigella sativa

Intervention Type DIETARY_SUPPLEMENT

Nigella sativa (200 mg, soft capsule)

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

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

Vitamin E (200 mg, soft capsule)

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin E

Vitamin E (200 mg, soft capsule)

Intervention Type DIETARY_SUPPLEMENT

Nigella sativa

Nigella sativa (200 mg, soft capsule)

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Prof. Mir Misbahuddin

Prof. and Chairman, Department of Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mir Misbahuddin, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

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Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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BSMMU-002-CT

Identifier Type: -

Identifier Source: org_study_id

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