Safety evaluation of Bon-santé cleanser® polyherbal in male Wistar rats

Abstract

BackgroundThe potential harm of medicinal herbs has been recently observed following herbal toxicity studies after ingestion of polyherbal remedies. This was the rationale for the food and drug regulatory agency decision for thorough safety evaluation of herbal medicines. Androgenic, antipyretic, analgesic and anti-inflammatory potentials as well as chemical compositions of extracts of massularia acuminata, terminalia ivorensis, anogeissus leiocarpus and macuna pruriens respectively have been documented. Thus, Bon-santé cleanser® (BSC) is formulated from these medicinal plants with the intention to boost body hormones and energizes the body. Considering the wide usage of BSC, we investigated on its safety in male Wistar rats.MethodsThirty-two male Wistar rats weighing 201.9 ± 7.5 g were grouped into four treatment groups of eight per group. Group I, (control) received distilled water (10 ml/kg). Groups II-IV received 250 mg/kg, 500 mg/kg and 1000 mg/kg of BSC per oral respectively. Each group was treated for sixty days.ResultsAcute toxicity test, in male Wistar albino mice, showed that LD50 was 600 mg/kg via i.p. while 4 g/kg was nonlethal after oral administration in mice. Hepatic and renal biomarker enzymes were unaltered in all rats. Increased in PCV (p <0.05) was observed at 500 mg/kg. BSC modulates antioxidants biomarkers following sub-chronic administration and increased serum Na+ (p >0.05). BSC at 1000 mg/kg caused mild inflammation of the liver and heart but not kidneys histologically.ConclusionsBSC has been found to be relatively safe in Wistar rats. Although, our findings indicate that herbal therapy with BSC should be done with caution as a mild alteration in the liver and heart architectures were observed.

Safety evaluation of Bon-santé cleanser ® polyherbal in male Wistar rats: Further investigations on androgenic and toxicological profile

“…The extraction and formulation procedures complied with the regulatory manual of NAFDAC. In this context, a single capsule of BSC (total content 442 mg) was prepared as previously reported 32 and administered via oral gavage according to standard toxicological guidelines.…”

“…Progressive sperm motility, sperm count, and sperm viability were then examined under the microscope attached to a Celestron ® Digital Microscope Imager (Torrance, CA 90503) and viewed under X40 objective according to the method described by Raji et al 34 and modified by Kale and Awodele. 32 Epididymal sperm motility was assessed by calculating motile spermatozoa per unit area and was expressed as percentage motility. Epididymal sperm count was done using the improved Neubauer hemocytometer and expressed as million/ml of suspension.…”

“…Recently, we assessed the safety of this preparation since it is being sold in public places and the manufacturers claimed they have many customers. 32 Further, the National Agency for Food and Drug Administration and Control enlists BSC among herbal products in Nigeria. Although, we found that BSC was relatively safe with mild alteration in the liver and heart architectures in rats, 32 but its acclaimed indications, however, cannot be juxtaposed on this fact, since no scientific investigations on efficacy have been carried out.…”

Toxicological evaluation of therapeutic and supra-therapeutic doses of Cellgevity® on reproductive function and biochemical indices in Wistar rats

“…An incision of about 1 mm was made in the caudal epididymis to liberate its spermatozoa into the saline solution. Progressive sperm motility, sperm count, and sperm viability were then examined under the microscope attached to a Celestron® Digital Microscope Imager (Torrance, CA 90503) and viewed under X40 objective as described elsewhere [ 18 ]. Epididymal sperm motility was assessed by calculating motile spermatozoa per unit area and was expressed as percentage motility.…”

“…Previous studies have reported that dietary supplements are now being used to prevent and treat various diseases [ 15 , 16 ]. However, a number of adverse events have been reported over the past few years with the use of herbs and herbal products [ 17 , 18 ]. Furthermore, concerns over drug-herbs interactions and irrational drug use (high dose) of CAM have arisen.…”