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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01731756

Enrollment

Registered

2012-11-22

Start date

2013-01-31

Completion date

2014-03-31

Last updated

2014-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arsenical Keratosis

Keywords

Palm, Arsenic, Keratosis, Salicylic acid, Azadirachta indica, Neem

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.

Interventions

OTHERLeaf 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.

DRUGSalicylic Acid (6%)

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

OTHERPetroleum jelly

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026