Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
This study has been completed.
Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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
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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 May 23, 2013