Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis

Arsenical Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735097
• Other study ID #: BSMMU-002-CT
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: May 2, 2014
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arsenical Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Dietary Supplement:
• Vitamin E
Vitamin E (200 mg, soft capsule)
• Nigella sativa
Nigella sativa (200 mg, soft capsule)
• Placebo
Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

Locations

Country	Name	City	State
Bangladesh	Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement of signs and symptoms of palmer arsenical keratosis	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	No
Secondary	Arsenic level in nails	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)	No
Secondary	Estimation of serum vitamin E levels	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)	No
Secondary	Estimation of serum total cholesterol levels	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)	No
Secondary	Liver function	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)	Yes
Secondary	Renal function	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)	Yes