90-days repeated dose oral toxicity study of sharbat-e-deenar (a hepatoprotective unani herbal formulation)

Sharbat-e-deenar (sdr) is a compound unani pharmacopoeial formulation recommended for the treatmentof waram-e-kabid (hepatitis), waram-e-rahem (uterine inflammation/ pelvic inflammatory diseases),yarqan-e-suddi (obstructive jaundice), and istisqa (ascites). the current study was carried outto investigate repeated dose oral toxicity study of sdr for 90 days in sprague dawley (sd) rats. sdrwas orally administered (gavage) at the doses of 4, 10 and 20 ml/kg bw/day. a periodic observationwas performed for mortality, morbidity and any clinical sign of toxicity. changes in body weight andfeed consumption were observed weekly throughout study duration. after the treatment duration ofthree months, animals were anaesthetized and blood samples were subjected to haematological investigationand serum was subjected to different biochemical estimation. gross necropsy was performedand internal organs/ tissues were processed for histopathological investigation. treatment with sdrshowed no incidence of mortality and no clinical sign of systemic toxicity. body weight showed patternof weight gain except significance decrease at mid and high dose at 13th week of study duration. feedconsumption exhibited a significant decrease as compare to control. haematology and biochemistryprofile found normal except certain isolated changes which was considered toxicologically not significantas the values lies in the normal physiological range. there were no changes observed in the grossnecropsy and relative organ weight data of control and sdr treated rats. it is reported that few of theanimals showed changes in liver at mid (2.5 times of therapeutic equivalent dose) and high dose (5times of therapeutic equivalent dose) in sdr treated animals that may be attributed to sdr treatment,however, associated liver function parameters like alt, ast and alp did not show any alteration ofliver function. based on the results of this study, it may be indicated that liver may be the target organfor toxicity if sdr is used above recommended therapeutic dose for longer duration.