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Browsing Protocols by Author "Chikowe, Ibrahim"

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    The toxicity and safety evaluation of Jenda herbal product(s) used for the management of covid-19 patients
    (Kamuzu University of Health Sciences, 2021-06-21) Chikowe, Ibrahim
    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.