Acute toxicity and repeated dose 28-day oral toxicity study of metriviv syrup in female rats

INTRODUCTION: Metriviv syrup is a poly-herbal formulation used as uterine tonic and for treating gynecological ailments such as infertility, leucorrhea, and menstrual disorders. There is no scientific data on the safety of this formulation available, therefore, its detail toxicity study in female albino rats was conducted. AIMS AND OBJECTIVE: Acute toxicity and repeated dose 28 days oral toxicity study of metriviv syrup in female rats. MATERIAL AND METHODS: In oral acute toxicity study, syrup metriviv was administered orally once only at the dose of 2000mg/kg in rats in a sequential manner. For repeated dose toxicity study, Metriviv syrup was administered orally for 28 consecutive days in albino rats at three dose levels, i.e., TED, TEDx5 and TEDx10 dose levels (1.35, 0.75, 13.5 ml/kg, twice a day respectively). RESULTS AND OBSERVATION: Results of acute toxicity study showed that drug did not produce any behavioral changes, signs of toxicity and mortality up to the dose of 2000 mg/kg in rats. In repeated dose 28-day oral toxicity study, Metriviv did not produce any signs of toxicity and changes in behavioral parameters. Metriviv did not affect cellular as well as non-cellular elements of the blood to significant extent. Serum biochemical profile and histological study clearly indicated that the test formulation is not likely to produce any serious changes at lower dose level while produced mild-to-moderate changes at TEDx10 dose level and same was reverted in recovery study after discontinuation of the drug. CONCLUSION: The study concluded that metriviv syrup is safe to administer up to dose of 2000 mg/kg in female rats during acute toxicity. In repeated dose 28-day oral toxicity study, test drug at TEDx10 has only mild-to-moderate adverse potential for liver and kidney while did not have any major toxic effects at therapeutic dose level in female albino rats.