Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
1 other identifier
interventional
60
1 country
1
Brief Summary
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedDecember 12, 2012
December 1, 2012
9 months
December 11, 2012
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the clinical symptom of keratosis in palm
0 week (baseline) to 12 weeks (end)
Secondary Outcomes (3)
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
0 week (baseline), 12 weeks (end)
Adverse effects following treament
0 week (baseline), 12 weeks (end)
Change in the amount of arsenic in nail
0 week (baseline), 20 weeks (end)
Study Arms (3)
Patients of palmer arsenical keratosis
EXPERIMENTALOne soft capsule of garlic oil (10 mg) daily for 12 weeks
Arsenic exposed controls
ACTIVE COMPARATOROne soft capsule of garlic oil (10 mg) daily for 12 weeks
Heathy volunteers
ACTIVE COMPARATOROne soft capsule of garlic oil (10 mg) daily for 12 weeks
Interventions
Oral administration
Eligibility Criteria
You may qualify if:
- history of taking arsenic contaminated water (\>50 ppb) for more than 6 months
- patients having mild to moderate arsenical keratosis present on palm of the hand
- patients those voluntarily agree to participate
- family member of the patient
- drinking arsenic contaminated water from the same source as patient
- those voluntarily agree to participate
- no sign/symptom of palmer keratosis
- drinking arsenic safe water (\<50 ppb)
- those voluntarily agree to participate
You may not qualify if:
- pregnancy
- lactating mother
- patient receiving treatment of arsenicosis
- any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mir Misbahuddin, MBBS, PhD
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. and Chairman, Department of Pharmacology
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 12, 2012
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
December 12, 2012
Record last verified: 2012-12