Virgin Coconut Oil Oral Supplementation for Leprosy Patients
Hansen's Disease
About this trial
This is an interventional supportive care trial for Hansen's Disease focused on measuring Leprosy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Philippine General Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Multi-Drug Therapy (Novartis Ⓡ)
Virgin Coconut Oil (VCO) with MDT
Multi-Drug Therapy PB pack consists of 600 milligrams (mg) of rifampicin (NovartisⓇ) single dose once a month and 100mg of dapsone (NovartisⓇ) daily for six months (PB patients) Multi-Drug Therapy MB pack consists of 600mg of rifampicin (NovartisⓇ), 300mg of clofazimine (NovartisⓇ) as a single dose monthly and 50mg of clofazimine (NovartisⓇ) and 100mg of dapsone (NovartisⓇ) daily for six months (MB patients)
VCO 10 milliliters (mL) three times a day in addition to MDT of 600mg of rifampicin (NovartisⓇ) single dose once a month and 100mg of dapsone (NovartisⓇ) daily for a period of six months (PB patients) VCO 10mL three times a day in addition to MDT of 600mg of rifampicin (NovartisⓇ), 300mg of clofazimine (NovartisⓇ) as a single dose monthly and 50mg of clofazimine (NovartisⓇ) and 100mg of dapsone (NovartisⓇ) daily or a period of six months (MB patients)