Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01748669
First received: December 11, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Arsenic Poisoning
Dietary Supplement: Garlic oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

Resource links provided by NLM:


Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Change in the clinical symptom of keratosis in palm [ Time Frame: 0 week (baseline) to 12 weeks (end) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: Yes ]
  • Adverse effects following treament [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: Yes ]
  • Change in the amount of arsenic in nail [ Time Frame: 0 week (baseline), 20 weeks (end) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748669

Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
Principal Investigator: Mir Misbahuddin, MBBS, PhD Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
  More Information

No publications provided

Responsible Party: Prof. Mir Misbahuddin, Prof. and Chairman, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01748669     History of Changes
Other Study ID Numbers: BSMMU-005-CT
Study First Received: December 11, 2012
Last Updated: December 11, 2012
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Arsenic
Arsenicosis
Garlic oil
Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Poisoning
Arsenic Poisoning
Skin Diseases
Precancerous Conditions
Neoplasms
Substance-Related Disorders
Heavy Metal Poisoning, Nervous System
Neurotoxicity Syndromes
Nervous System Diseases
Allyl sulfide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014