The toxicity and safety evaluation of Jenda herbal product(s) used for the management of covid-19 patients
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Date
2021-06-21
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Kamuzu University of Health Sciences
Abstract
Type of study: This will be a retrospective case study and prospective laboratory in-vitro study evaluating the toxicity
of Jenda herbal product in patients.
Problem:
In Malawi, several herbal practitioners have claimed the effectiveness of their herbal products against
symptoms associated with COVID-19 disease. Despite the lack of data on quality control, safety and
efficacy of the products, many people have confidence in the traditional interventions offered to them.
Some of the herbal practitioners have challenged scientists to test their products for efficacy and
safety. This comes on the wheels of the fact that unlike the many plants in the Chinese medicines,
Malawian medicinal plants lack documented efficacy, toxicity and safety data against the
practitioners’ claims, which prevents them from being taken directly into clinical testing despite their
long term use. Yet, calls have been made to assess the efficacy of the herbal products in a clinical
setting in Malawi (Mzungu, 2020).This study seeks to fill the gap on one of the products being
produced by one of the herbal practitioners, who has also challenged the scientists to evaluate his
product for toxicity and efficacy. However, based on the principle of ‘primum non nocere’ (‘first, not
do harm’) (Pierantozzi, 2013), the study firstly assesses the toxicity of the herbal product before
looking at the efficacy.
Aim:
The study evaluates the toxicity and safety of Jenda herbal product that is widely being used for the
management of COVID-19 patients in Malawi.
Study objectives:
The objectives of the study include screening phytochemicals of the herbal product, assessing acute
and sub-acute toxicity of the herbal preparation in patients and evaluating the toxicity and safety of the
herbal product
Hypothesis:
Jenda herbal product is a safe herbal product that can be used in the management of Covid -19 like
symptoms and signs. Method
This will be a mixed methods study involving qualitative (laboratory and survey) and quantitative
(laboratory and survey) methods. The aqueous Jenda herbal product will be qualit at ively
screened for phytochemical constituents such as flavonoids, phenols, alkaloids and others.
Quant it at ive Antioxidant activity will be done using the free radical scavenging capacity of
2,2-Diphenyl-1-Picrylhydrazil radical (DPPH) method. Gas Column Chromatography will be used to
fingerprint non-volatile compounds. Acute toxicity studies will be done using brine shrimp. All the
tests will be done using various published and standardized methods. Qualitative and quantitative
The case study data collection will involve 40 volunteers (either male or female) that used Jenda
herbal product to manage Covid-19 like symptoms from 23 July 2020 to 07 Mar 2021using key
informant interviews. Participants will be requested to respond to a questionnaire and submit urine
samples for biochemical analysis after informed consent. Quantitative data will be analyzed
descriptively using STATA software while qualitative data will be analysed using thematic analysis
coupled with N-VIVO software.
Expected findings:
The study expects to find no acute or sub-acute toxicity results both in human subjects and brine
shrimp model.
Dissemination:
Findings from this study will be sent to CoMREC and College of Medicine library. Publications
will also be made in peer reviewed journals.