Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

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

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

Study Overview

• Status: Completed
• Conditions: Arsenical Keratosis
• Intervention / Treatment: Other: Leaf extract of A. indica; Drug: Salicylic Acid (6%); Other: Petroleum jelly

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palmer arsenical keratosis (study); 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	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.
Placebo Comparator: Palmer arsenical keratosis (control); Salicylic acid (6%) in petroleum jelly base 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 18, 2012
• First Posted (Estimate): November 22, 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: Arsenic; Salicylic acid; Keratosis; Palm; Azadirachta indica; Neem
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Emollients; Salicylic Acid; Salicylates; Petrolatum
• Other Study ID Numbers: BSMMU-003-CT