Clinical trial NCT01748669: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Arsenic Poisoning
Keywords: Arsenic
Arsenicosis
Garlic oil
Keratosis
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the clinical symptom of keratosis in palm
timeFrame: 0 week (baseline) to 12 weeks (end)
Secondary outcomes:
measure: Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Adverse effects following treament
timeFrame: 0 week (baseline), 12 weeks (end)
measure: Change in the amount of arsenic in nail
timeFrame: 0 week (baseline), 20 weeks (end)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
Study officials:
affiliation: Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
name: Mir Misbahuddin, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: