Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
20 Years
60 Years
Both
Chronic Arsenic Poisoning
Trial Information
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in the clinical symptom of keratosis in palm
Outcome Time Frame:
0 week (baseline) to 12 weeks (end)
Safety Issue:
No
Principal Investigator
Mir Misbahuddin, MBBS, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Authority:
Bangladesh: Ethical Review Committee
Study ID:
BSMMU-005-CT
NCT ID:
NCT01748669
Start Date:
October 2011
Completion Date:
July 2012
Related Keywords:
- Chronic Arsenic Poisoning
- Arsenic
- Arsenicosis
- Garlic oil
- Keratosis
- Keratosis
- Keratosis, Actinic
- Poisoning
- Arsenic Poisoning
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