- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748669
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh
- Bangabandhu Sheikh Mujib Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients of palmer arsenical keratosis
One soft capsule of garlic oil (10 mg) daily for 12 weeks
|
Oral administration
|
Active Comparator: Arsenic exposed controls
One soft capsule of garlic oil (10 mg) daily for 12 weeks
|
Oral administration
|
Active Comparator: Heathy volunteers
One soft capsule of garlic oil (10 mg) daily for 12 weeks
|
Oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the clinical symptom of keratosis in palm
Time Frame: 0 week (baseline) to 12 weeks (end)
|
0 week (baseline) to 12 weeks (end)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
Time Frame: 0 week (baseline), 12 weeks (end)
|
0 week (baseline), 12 weeks (end)
|
Adverse effects following treament
Time Frame: 0 week (baseline), 12 weeks (end)
|
0 week (baseline), 12 weeks (end)
|
Change in the amount of arsenic in nail
Time Frame: 0 week (baseline), 20 weeks (end)
|
0 week (baseline), 20 weeks (end)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mir Misbahuddin, MBBS, PhD, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Precancerous Conditions
- Neurotoxicity Syndromes
- Heavy Metal Poisoning, Nervous System
- Poisoning
- Keratosis, Actinic
- Keratosis
- Arsenic Poisoning
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protective Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antioxidants
- Anticarcinogenic Agents
- Allyl sulfide
Other Study ID Numbers
- BSMMU-005-CT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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