Skip to main content
OpenTrials
Completed

NCT Number: NCT01731756

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-control trial

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arsenical Keratosis Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leaf extract of A. indica

Other

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

Salicylic Acid (6%)

Drug

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

Petroleum jelly

Other

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

Primary outcomes

  1. Changes in palmer arsenical keratosis

    Time frame: 0 week (baseline), 12 weeks (end)

    Size and number of keratotic lesions will be reduced. These will be expressed in score.

Secondary outcomes

  1. Changes in arsenic level in nail

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 22, 2012
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.