Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
Primary Purpose
Chronic Arsenic Poisoning
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Garlic oil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Arsenic Poisoning focused on measuring Arsenic, Arsenicosis, Garlic oil, Keratosis
Eligibility Criteria
Inclusion Criteria (Patients):
- 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
Inclusion Criteria (Arsenic exposed controls):
- 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
Inclusion Criteria (Healthy volunteers):
- drinking arsenic safe water (<50 ppb)
- those voluntarily agree to participate
Exclusion Criteria:
- pregnancy
- lactating mother
- patient receiving treatment of arsenicosis
- any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
Sites / Locations
- Bangabandhu Sheikh Mujib Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Patients of palmer arsenical keratosis
Arsenic exposed controls
Heathy volunteers
Arm Description
One soft capsule of garlic oil (10 mg) daily for 12 weeks
One soft capsule of garlic oil (10 mg) daily for 12 weeks
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Outcomes
Primary Outcome Measures
Change in the clinical symptom of keratosis in palm
Secondary Outcome Measures
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
Adverse effects following treament
Change in the amount of arsenic in nail
Full Information
NCT ID
NCT01748669
First Posted
December 11, 2012
Last Updated
December 11, 2012
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT01748669
Brief Title
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
Official Title
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment.
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Arsenic Poisoning
Keywords
Arsenic, Arsenicosis, Garlic oil, Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients of palmer arsenical keratosis
Arm Type
Experimental
Arm Description
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Arm Title
Arsenic exposed controls
Arm Type
Active Comparator
Arm Description
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Arm Title
Heathy volunteers
Arm Type
Active Comparator
Arm Description
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Garlic oil
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Change in the clinical symptom of keratosis in palm
Time Frame
0 week (baseline) to 12 weeks (end)
Secondary Outcome Measure Information:
Title
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
Time Frame
0 week (baseline), 12 weeks (end)
Title
Adverse effects following treament
Time Frame
0 week (baseline), 12 weeks (end)
Title
Change in the amount of arsenic in nail
Time Frame
0 week (baseline), 20 weeks (end)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Patients):
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
Inclusion Criteria (Arsenic exposed controls):
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
Inclusion Criteria (Healthy volunteers):
drinking arsenic safe water (<50 ppb)
those voluntarily agree to participate
Exclusion Criteria:
pregnancy
lactating mother
patient receiving treatment of arsenicosis
any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Misbahuddin, MBBS, PhD
Organizational Affiliation
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
We'll reach out to this number within 24 hrs