Status:
WITHDRAWN
Virgin Coconut Oil Oral Supplementation for Leprosy Patients
Lead Sponsor:
Philippine Dermatological Society
Conditions:
Hansen's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To date, there has been no clinical investigation on the effects of virgin coconut oil (VCO) oral supplementation on patients with Hansen's disease (HD) undergoing medical treatment. This study aims t...
Detailed Description
Objective: To determine the effect of co-administration of virgin coconut oil (VCO) oral supplementation and standard Multi-Drug Therapy (MDT) on malondialdehyde (MDA), superoxide dismutase (SOD), and...
Eligibility Criteria
Inclusion
- Patients aged 18 years and above, male or female
- Patients with clinical evidence and histological confirmation of lepromatous leprosy (LL), borderline lepromatous leprosy (BL), borderline leprosy (BB), borderline tuberculoid leprosy (BT), or tuberculoid leprosy (TT) according to the Ridley and Jopling classification and Paucibacillary (PB) or Multibacillary (MB) disease based on the World Health Organization (WHO) classification
- Patients should not have been on MDT in the past
- Patients with normal blood test results for complete blood count (CBC), liver aminotransaminases (AST, ALT), glucose-6-phosphate dehydrogenase (G6PD) assay, creatinine, lipid profile and chest x-ray
Exclusion
- HD patients with reactions needing prednisone therapy at time of diagnosis
- Patients who are already taking VCO or any other oral or intravenous antioxidant supplements
- Patients taking long term medications unrelated to leprosy
- Pregnant women
- Patients with history of smoking, co-infections such as tuberculosis, diabetes mellitus, any other systemic diseases or health problems
- Patients not willing to return for follow-up
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01885611
Start Date
June 1 2013
End Date
June 1 2018
Last Update
April 5 2017
Active Locations (1)
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1
Philippine General Hospital
Manila, Manila, Philippines, 1000