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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01748669
Other study ID # BSMMU-005-CT
Secondary ID
Status Completed
Phase Phase 2
First received December 11, 2012
Last updated December 11, 2012
Start date October 2011
Est. completion date July 2012

Study information

Verified date December 2012
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact n/a
Is FDA regulated No
Health authority Bangladesh: Ethical Review Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Garlic oil
Oral administration

Locations

Country Name City State
Bangladesh Bangabandhu Sheikh Mujib Medical University Dhaka

Sponsors (1)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the clinical symptom of keratosis in palm 0 week (baseline) to 12 weeks (end) No
Secondary Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment 0 week (baseline), 12 weeks (end) Yes
Secondary Adverse effects following treament 0 week (baseline), 12 weeks (end) Yes
Secondary Change in the amount of arsenic in nail 0 week (baseline), 20 weeks (end) No
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Completed NCT02908581 - Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis Phase 2
Completed NCT03127657 - Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion Phase 2
Completed NCT01726426 - Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics N/A