Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis

NCT ID: NCT01748669

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Arsenic Poisoning

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Arsenic Arsenicosis Garlic oil Keratosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients of palmer arsenical keratosis

One soft capsule of garlic oil (10 mg) daily for 12 weeks

Group Type EXPERIMENTAL

Garlic oil

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Arsenic exposed controls

One soft capsule of garlic oil (10 mg) daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Garlic oil

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Heathy volunteers

One soft capsule of garlic oil (10 mg) daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Garlic oil

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Garlic oil

Oral administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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


* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Mir Misbahuddin

Prof. and Chairman, Department of Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mir Misbahuddin, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bangladesh

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BSMMU-005-CT

Identifier Type: -

Identifier Source: org_study_id