Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 13, 2016
January 1, 2016
6 months
January 28, 2015
January 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in palmer arsenical keratosis
Size of keratotic lesion will be decreased
0 weeks (baseline), 12 weeks (end)
Secondary Outcomes (1)
Changes in arsenic level in nail
0 weeks (baseline), 12 weeks (end)
Study Arms (2)
Patients treated with 3 drugs
EXPERIMENTALNeem plus propylene glycol plus salicylic acid: Neem extract, propylene glycol (40%) and salicylic acid (10%) once daily on palm for 12 weeks
Patients treated with 1 drug
ACTIVE COMPARATORSalicylic acid once daily on palm for 12 weeks
Interventions
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 (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks
Eligibility Criteria
You may qualify if:
- Age: 18-60 years
- Palmar arsenical keratosis
- Drinking arsenic contaminated water (\>50 µg/L) for more than six months
- Patient voluntarily agree to participate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muradnagar Health Complex
Comilla, Bangladesh
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mir Misbahuddin
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
January 28, 2015
First Posted
February 2, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
January 13, 2016
Record last verified: 2016-01