Quality assessment and clinical evaluation of the safety and effectiveness of a Ghanaian hepatorestorative polyherbal product (HPK) at the Wa Regional Hospital

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Liver diseases are increasing globally and many clients in developing countries tend to use herbal products for their treatment but most of these products have not been studied scientifically. The study aimed at assessing quality, safety and effectiveness outcomes of the treatment of patients with deranged liver functions using a Ghanaian polyherbal product, HPK. HPK which is used as a hepatorestorative is a decoction prepared from Bidens pilosa, Citrus aurantifolia and Trema orientalis. Quality parameters of HPK were assessed through physicochemical, microbiological, spectroscopic and chromatographic analysis. Atomic Absorption Spectroscopy (AAS) was used for heavy metals analysis. Fifty clients with laboratory-confirmed deranged liver function gave informed consent and were recruited for the study at the Upper West Regional Hospital. Participants took HPK (30 mL 8 hourly) for 28 days. Laboratory investigations (LFT, RFT, FBC and Urine R/E) were undertaken at day 0 (baseline), 14 and 28 to assess for safety and effectiveness of HPK. HPK exhibited DPPH free radical scavenging activity with IC50 of 23.39µg. HPK contains reducing sugars, alkaloids, tannins, saponins, coumarins, flavonoids and phytosterols. HPLC, TLC, UV and IR fingerprints have been established. Microbiological cultures did not show any observable contamination of the HPK. Heavy metal analysis: Lead, Mercury, Nickel, Cadmium and Arsenic yielded content levels within the safe WHO reference ranges. Compared to baseline values, HPK showed no observable toxicity on renal function, haematological parameters and urinalysis in humans after 28 day period. However, HPK significantly improved the liver function of the participants: AST (p - 0.0001), ALT (p < 0.0001), GGT (p - 0.0017), total bilirubin (p - 0.0146), direct bilirubin (p < 0.0001) and alkaline phosphates (p -0.0295). The other parameters showed no significant differences in 28 days. Within the limits of the study, HPK had hepatorestorative action with no observable toxicity and can be used with confidence as indicated on its label as a liver tonic.
A thesis submitted to the Department of Pharmacognosy, Kwame Nkrumah University of Science and Technology, Kumasi in partial fulfilment of the requirements for the award Degree of Master of Philosophy in Pharmacognosy, 2019.
Quality Assessment, Clinical Evaluation, Safety, Effectivenes, Ghanaian, Hepatorestorative Polyherbal Product, Wa Regional Hospital