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Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Primary Purpose

Arsenical Keratosis

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Leaf extract of A. indica
Salicylic Acid (6%)
Petroleum jelly
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arsenical Keratosis focused on measuring Palm, Arsenic, Keratosis, Salicylic acid, Azadirachta indica, Neem

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Palmer arsenical keratosis (study)

Palmer arsenical keratosis (control)

Arm Description

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

Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

Outcomes

Primary Outcome Measures

Changes in palmer arsenical keratosis
Size and number of keratotic lesions will be reduced. These will be expressed in score.

Secondary Outcome Measures

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.

Full Information

First Posted
November 16, 2012
Last Updated
May 2, 2014
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01731756
Brief Title
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis
Official Title
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arsenical Keratosis
Keywords
Palm, Arsenic, Keratosis, Salicylic acid, Azadirachta indica, Neem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palmer arsenical keratosis (study)
Arm Type
Experimental
Arm Description
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
Arm Title
Palmer arsenical keratosis (control)
Arm Type
Placebo Comparator
Arm Description
Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
Intervention Type
Other
Intervention Name(s)
Leaf extract of A. indica
Intervention Description
Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Salicylic Acid (6%)
Intervention Description
Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Petroleum jelly
Intervention Description
Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
Primary Outcome Measure Information:
Title
Changes in palmer arsenical keratosis
Description
Size and number of keratotic lesions will be reduced. These will be expressed in score.
Time Frame
0 week (baseline), 12 weeks (end)
Secondary Outcome Measure Information:
Title
Changes in arsenic level in nail
Description
Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.
Time Frame
0 week (baseline), 12 weeks (end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Misbahuddin, MBBS, PhD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Learn more about this trial

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

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