Safety profile of a polyherbal formulation (Gynocare capsules) in female rats by subchronic oral toxicity study

Abstract

Gynocare capsules, is a polyherbal formulation, are used as uterine tonic and for treating gynaecological ailments like infertility, leucorrhea, and menstrual disorders. The formulation contains ingredients of herbal origin, such as, extracts of Ashoka, Vasaka, Durva, Chandan, Musk, and so on. It was evaluated for its safety at the therapeutic dose level by a repeated dose oral toxicity study in albino Wistar rats. The herbal formulation was administered orally at a therapeutic dose of 100 mg/kg/day, for 90 days. All animals were monitored daily for their health status and signs of abnormalities. The body weight, water consumption, and food intake were measured once weekly. At the end of the experimental period, various hematological and biochemical parameters were estimated and histopathologies of selected organs were conducted. The study resulted from the long-term oral administration of Gynocare capsules (100 mg/kg), did not cause any relevant signs of toxicity nor significant changes in the physical, hematological and biochemical parameters. However, statistically significant differences were seen in the relative organ weights of adrenal gland, ovary, and serum creatinine levels. The reduction in ovary weight revealed the possibility of the drug targeting the ovary. Moreover, no pathological features were identified in the treated group as monitored by the histopathological analysis of the internal organs. The study established that Gynocare capsules at the dose given (100 mg/kg) did not induce any remarkable or significant toxic effects, indicating that it was safe in rats following oral administration for 90 consecutive days.

Pharmacological Evaluation of Safoof-e-Pathar Phori- A Polyherbal Unani Formulation for Urolithiasis

“…They have been shown to possess undeniable and tangible therapeutic benefits with limited toxicity because of their long-term use as traditional medicines. The WHO claims that safety is a critical parameter of herbal medicines in the quality control of healthcare products ( Tatke et al, 2012 ). Toxicity studies are considered to be important during new drug development, keeping in mind that herbal medicines are frequently used indiscriminately without considering their potential side effects, which can vary from mild–severe to life-threatening ( World Health Organization, 1987 ; World Health Organization, 2000 ).…”

“…Toxicity studies are considered to be important during new drug development, keeping in mind that herbal medicines are frequently used indiscriminately without considering their potential side effects, which can vary from mild–severe to life-threatening ( World Health Organization, 1987 ; World Health Organization, 2000 ). Various herbal preparations have been shown to be beneficial in treating kidney disease; however, the toxicity and safety data for many of these herbal treatments are not available ( Tatke et al, 2012 ).…”

In Vivo Safety of Aqueous Leaf Extract of Lippia javanica in Mice Models

“…Toxicity studies are fundamental in evaluation of safety of extracts or drugs used in clinical medicine [1]. The short or long-term administration of a chemical compound may bring about significant changes in the function, metabolic transformation, structure and concentration of biomolecules, enzymes and even metabolic pathways [2].…”

Acute and 26-Week Repeated Oral Dose Toxicity Study of UP446, a Combination of <i>Scutellaria</i> Extract and <i>Acacia</i> Extract in Rats

“…These formulations are used by large sections of the human population particularly in developed countries. Many synthetic drugs are known to act on a single molecular target but the multitarget responses of herbal formulations are proven to be beneficial in chronic conditions [1][2][3]. The World Health Organization (WHO) insists that the safety of herbal medicines is a critical component in the quality control of healthcare products.…”