Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 2

Conditions: Chronic Arsenic Poisoning

Treatments: Dietary Supplement: Garlic oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01748669

BSMMU-005-CT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Patients of palmer arsenical keratosis

Experimental group

Description:

One soft capsule of garlic oil (10 mg) daily for 12 weeks

Treatment:

Dietary Supplement: Garlic oil

Arsenic exposed controls

Active Comparator group

Description:

One soft capsule of garlic oil (10 mg) daily for 12 weeks

Treatment:

Dietary Supplement: Garlic oil

Heathy volunteers

Active Comparator group

Description:

One soft capsule of garlic oil (10 mg) daily for 12 weeks

Treatment:

Dietary Supplement: Garlic oil