Hansen's Disease Clinical Trial
Official title:
The Effects of Virgin Coconut Oil Supplementation on Oxidative Stress and Treatment Response Among Hansen's Disease Patients on Multi-Drug Therapy: A Pilot Study
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 to examine the possible protective effect of exogenous supplementation of VCO on the oxidative stress, antioxidant status, and treatment response among HD patients. Treatment response will be defined as the clinical changes in cutaneous and neurologic manifestations as measured by the clinical response score. This study also aims to investigate the potential of VCO as an adjunct to Multi-Drug Therapy (MDT) in mitigating lepra reactions.
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 glutathione (GSH) blood levels and to determine and compare treatment
response between leprosy cases treated with MDT alone and cases treated with MDT with VCO
supplementation.
Design: This is an open label, controlled clinical trial and a preliminary/phase 1 trial.
Setting: Patients seen in the out-patient clinic of the Section of Dermatology, Philippine
General Hospital, a tertiary government hospital.
Participants: Twenty-six previously untreated Hansen's Disease (HD) patients, 18 years old
and above, diagnosed clinically and confirmed histologically with HD.
Intervention: The 26 HD patients will be divided into two groups: group 1 will receive only
MDT and group 2 will receive MDT with VCO supplementation. Both groups 1 and 2 will consist
of 6 or 7 Paucibacillary (PB) patients and 6 or 7 Multibacillary (MB) patients. All
participants will have MDA, SOD, and GSH blood levels taken on initial consult and on the
third and sixth months. Treatment response will be measured by a clinical response score,
which will be graded by a blinded investigator based on cutaneous manifestations (no change,
moderate improvement, definite improvement, worse) and neurologic manifestations (no change,
improvement, worse).
Main Outcome Measures: The mean and inter-quartile range of MDA, SOD, and GSH blood levels;
bacterial index (BI) and morphological index (MI) from slit skin-smears; and treatment
response based on the clinical response score. Frequency and severity of lepra reactions
will also be noted.
Data Analysis: The following statistical tests will be used: Mann-Whitney test to compare
the difference between median values of group 1 and group 2; Kruskal-Wallis Test for
multiple comparisons; Wilcoxon signed ranks test for comparing differences in median values
within groups; Fisher's exact test to compare the frequency of categorical data of treatment
response (cutaneous manifestations); and T test for the quantitative data (neurologic
manifestations) will be used. Values of p<0.05 will be considered statistically significant.
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