Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Chronic Arsenic Poisoning Clinical Trial

Official title:

Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748669
• Other study ID #: BSMMU-005-CT
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2012
• Last updated: December 11, 2012
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arsenic Poisoning
• Chronic Arsenic Poisoning
• Keratosis

Intervention

Dietary Supplement:
• Garlic oil
Oral administration

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical symptom of keratosis in palm		0 week (baseline) to 12 weeks (end)	No
Secondary	Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment		0 week (baseline), 12 weeks (end)	Yes
Secondary	Adverse effects following treament		0 week (baseline), 12 weeks (end)	Yes
Secondary	Change in the amount of arsenic in nail		0 week (baseline), 20 weeks (end)	No