Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Arsenical Keratosis Clinical Trial

Official title:

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731756
• Other study ID #: BSMMU-003-CT
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: May 2, 2014
• Start date: January 2013
• Est. completion date: March 2014

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

Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

Description:

The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Palmer arsenical keratosis

• Drinking arsenic contaminated water (>50 ppb) for more than six months

• Patient voluntarily agree to participate

Exclusion Criteria:

• Pregnancy

• Lactating mother

• Diabetes mellitus

• Rheumatoid arthritis

• Systemic lupus erythematosus

• Psoriasis

• Bowen's disease

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

Other:
• Leaf extract of A. indica
Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

Drug:
• Salicylic Acid (6%)
Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.

Other:
• Petroleum jelly
Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.

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	Changes in palmer arsenical keratosis	Size and number of keratotic lesions will be reduced. These will be expressed in score.	0 week (baseline), 12 weeks (end)	No
Secondary	Changes in arsenic level in nail	Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.	0 week (baseline), 12 weeks (end)	No