Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

December 11, 2012 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Bangabandhu Sheikh Mujib Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients of palmer arsenical keratosis
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Dietary supplement: Garlic oil
Oral administration
Active Comparator: Arsenic exposed controls
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Dietary supplement: Garlic oil
Oral administration
Active Comparator: Heathy volunteers
One soft capsule of garlic oil (10 mg) daily for 12 weeks
Dietary supplement: Garlic oil
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the clinical symptom of keratosis in palm
Time Frame: 0 week (baseline) to 12 weeks (end)
0 week (baseline) to 12 weeks (end)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Mir Misbahuddin, MBBS, PhD, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU-005-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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