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OpenTrials
Completed

NCT Number: NCT01748669

Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

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.

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Key information

Conditions

Chronic Arsenic Poisoning Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garlic oil

Dietary Supplement

Oral administration

Primary outcomes

  1. Change in the clinical symptom of keratosis in palm

    Time frame: 0 week (baseline) to 12 weeks (end)

Secondary outcomes

  1. Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment

    Time frame: 0 week (baseline), 12 weeks (end)

  2. Adverse effects following treament

    Time frame: 0 week (baseline), 12 weeks (end)

  3. Change in the amount of arsenic in nail

    Time frame: 0 week (baseline), 20 weeks (end)

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 12, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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