Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis

NCT ID: NCT02352987

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-09-30

Brief Summary

This study is designed to find out the effectiveness of combination of ethanol extract of neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis.

Detailed Description

Arsenic, a non-essential trace element, is a major water pollutant in Bangladesh. Arsenical keratosis, which occurs in the palm and sole, is a common symptom of arsenicosis. The objective of this study is to find the effectiveness of combination of topical administration of the ethanol extract of leaf of neem (Azadirachta indica), propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar arsenical keratosis. On the basis of inclusion and exclusion criteria, 30 patients of moderate palmar arsenical keratosis will be recruited from an arsenic affected area. They will be divided into two groups: study group and placebo comparator group. Each group consisting of 15 members. Study group will be given combination of ethanol extract of leaf of neem, propylene glycol (40%) and salicylic acid (10%) to apply on palm overnight once daily for 12 weeks. On the other hand placebo comparator group will be given salicylic (10%) acid to apply on palm overnight once daily for 12 weeks. Water and nail samples will be collected before starting recruitment to confirm arsenicosis. After conclusive recruitment of the subjects the objective, nature, purpose and potential risks and benefits of all procedures of the study will be explained in details to the patients and informed written consent will be taken from them. Detail history, clinical examination and photograph (palm) will also be collected. Clinical improvement will be assessed by measuring palmar nodular size on both hands, before starting treatment and after 12 weeks completion of treatment and perception of patients about their improvement. The study will explore the effectiveness of topical use of combination of ethanol extract of neem, propylene glycol and salicylic acid for the treatment of palmar arsenical keratosis.

Conditions

Chronic Arsenic Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients treated with 3 drugs

Neem plus propylene glycol plus salicylic acid: Neem extract, propylene glycol (40%) and salicylic acid (10%) once daily on palm for 12 weeks

Group Type: EXPERIMENTAL

Neem plus propylene glycol plus salicylic acid

Intervention Type: DRUG

Leaf extract of neem plus propylene glycol (40%) plus salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks

Patients treated with 1 drug

Salicylic acid once daily on palm for 12 weeks

Group Type: ACTIVE_COMPARATOR

Salicylic acid

Intervention Type: DRUG

salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks

Interventions

Neem plus propylene glycol plus salicylic acid

Leaf extract of neem plus propylene glycol (40%) plus salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks

Intervention Type: DRUG

Salicylic acid

salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks

Intervention Type: DRUG

Other Intervention Names

In house prepared; In house prepared

Eligibility Criteria

Inclusion Criteria

• Age: 18-60 years
• Palmar arsenical keratosis
• Drinking arsenic contaminated water (>50 µg/L) for more than six months
• Patient voluntarily agree to participate

Exclusion Criteria

• Pregnancy and lactating mother
• Skin lesion :Psoriasis and eczema
• Bowen's disease
• Any kind of systemic disease, inflammatory disease and infectious condition that affect skin (Diabetes mellitus, Rheumatoid arthritis, Systemic lupus erythematosus , Hepatitis and Tuberculosis)
• Hypersensitivity to any drug
• Patient who received treatment within last three months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Prof. Mir Misbahuddin

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mir Misbahuddin

Role: STUDY_DIRECTOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Muradnagar Health Complex

Comilla, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU-008-CT

Identifier Type: -

Identifier Source: org_study_id