Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Phase 2

Completed

• Conditions: Chronic Arsenic Poisoning
• Interventions: Dietary Supplement: Garlic oil

• Registration Number: NCT01748669
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-11
• Last Update Submitted: 2012-12-11
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• pregnancy
• lactating mother
• patient receiving treatment of arsenicosis
• any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arsenic exposed controls	Garlic oil	One soft capsule of garlic oil (10 mg) daily for 12 weeks
Patients of palmer arsenical keratosis	Garlic oil	One soft capsule of garlic oil (10 mg) daily for 12 weeks
Heathy volunteers	Garlic oil	One soft capsule of garlic oil (10 mg) daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in the clinical symptom of keratosis in palm	0 week (baseline) to 12 weeks (end)

Secondary Outcome Measures

Name	Time	Method
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment	0 week (baseline), 12 weeks (end)
Adverse effects following treament	0 week (baseline), 12 weeks (end)
Change in the amount of arsenic in nail	0 week (baseline), 20 weeks (end)

Trial Locations

Locations (1)

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh