Evaluation of Toxicological Profile of a Polyherbal Formulation

Abstract

In current study toxicological profile of a commonly used herbal formulation was evaluated that is used extensively for gynecological disorders like menorrhagia, metrorrhagia, leucorrhea, irregular menstrual cycle, pre-menstrual syndrome and post-menopausal bleeding. It was also claimed to strengthen endometrium and ovaries. Since this herbal formulation was been used by a large number of population hence there was a need to assess acute and sub-chronic toxicity. Acute oral toxicity (LD50) was observed in albino mice using standard protocols whereas sub-chronic, hematological and histopathological studies were assessed on 24 albino rabbits after giving herbal formulation for 60 days in two doses (20 and 60 mg/kg) against control groups. The outcomes of present study showed that the drug is safe up to 5000 mg/kg following acute oral toxicity test and no mortality was observed during sub chronic toxicity studies. Results of sub-chronic toxicity did not show any significant changes in biochemical, hematological and histopathological parameters. However, some indicators such as urea, creatinine, hemoglobin, and RBC count were altered, but these changes do not correlate with the histopathological results and may be associated to intra individual variations. Despite the safety of the drug in few animals, clinical trials and more investigations on a large number of animals are essentially needed to establish safety and efficacy of the herbal formulation.

Anticancer, antioxidant, and acute toxicity studies of a Saudi polyherbal formulation, PHF5

“…The toxic effect of the PHF5 extract may be attributed to the presence of one or more phyto-compounds, which have a toxic impact on the animal model. Similar results were found in an acute and sub-acute toxicity study of a Pakistani polyherbal formulation [30,31] and in an investigation of Chinese traditional medicine when an herbal formula was used in patients. However, liver toxicity was attributed to overdosing [32].…”

Anti-inflammatory and Analgesic Activity of Cleome brachycarpa Ethanolic Extract in Lower Mammals and Effects on Blood and Liver Enzymes

“…A total of 40 Wistar strain albino rats of 200 ± 5 g (10 weeks of age), 30 mice of 30 ± 2 g (10 weeks of age), and 60 rabbits of 1000 -1500 g (10 months of age) were gathered from a retained and renowned animal house of Baqai Institute of Pharmaceutical Sciences (BIPS). Rabbits were selected for this evaluation because they have similar hematological variations to humans (29). All animals were housed in the animal house for 12/12-hour light/dark cycles at 25 ± 2°C temperature.…”

Biological Properties of Polyherbal Formulations: A Review of their Antimicrobial, Anti-Inflammatory, Antioxidant, and Toxicological Activities

“…The liver photomicrographs showed that treatment of animals with the polyherbal mixtures did not induce any visible lesions or derangements in the examined organ. [77][78][79][80][81][82][83][84] However, in the sub-acute toxicity study of Hab-e-Kabad Noshadri tablets used for the treatment of hepatitis, enlargement of liver at doses of 100 and and 200 mg/kg/day, morphological changes with some damage in liver and kidney tissues of male and female animals was observed. Hence, prolonged use at higher dose i.e.…”