Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Not Applicable

Completed

• Conditions: Arsenical Keratosis
• Interventions: Other: Leaf extract of A. indica; Drug: Salicylic Acid (6%); Other: Petroleum jelly

• Registration Number: NCT01731756
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-18
• Study First Posted: 2012-11-22
• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palmer arsenical keratosis (study)	Leaf extract of A. indica	Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
Palmer arsenical keratosis (study)	Salicylic Acid (6%)	Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
Palmer arsenical keratosis (study)	Petroleum jelly	Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
Palmer arsenical keratosis (control)	Salicylic Acid (6%)	Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
Palmer arsenical keratosis (control)	Petroleum jelly	Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in palmer arsenical keratosis	0 week (baseline), 12 weeks (end)	Size and number of keratotic lesions will be reduced. These will be expressed in score.

Secondary Outcome Measures

Name	Time	Method
Changes in arsenic level in nail	0 week (baseline), 12 weeks (end)	Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.

Trial Locations

Locations (1)

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh