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

Chronic Arsenic Poisoning Clinical Trial

Official title:

Randomized, Single Blind, Placebo Controlled Clinical Trial to See the Effect of Combination of Neem, Propylene Glycol and Salicylic Acid in the Treatment of Arsenical Palmar Keratosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352987
• Other study ID #: BSMMU-008-CT
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2015
• Last updated: January 11, 2016
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arsenic Poisoning
• Chronic Arsenic Poisoning

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Muradnagar Health Complex	Comilla

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in palmer arsenical keratosis	Size of keratotic lesion will be decreased	0 weeks (baseline), 12 weeks (end)	No
Secondary	Changes in arsenic level in nail	Arsenic level in nail will be decreased	0 weeks (baseline), 12 weeks (end)	No