Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status: Completed

Conditions: Arsenical Keratosis

Treatments: Drug: Salicylic Acid (6%); Other: Leaf extract of A. indica; Other: Petroleum jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT01731756

BSMMU-003-CT

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Palmer arsenical keratosis (study)

Experimental group

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

Treatment:

Other: Leaf extract of A. indica

Drug: Salicylic Acid (6%)

Other: Petroleum jelly

Palmer arsenical keratosis (control)

Placebo Comparator group

Description:

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

Treatment:

Drug: Salicylic Acid (6%)

Other: Petroleum jelly