title: Safety evaluation of Trikatu, a generic Ayurvedic medicine in Charles Foster rats.
abstract: Chemical characterization and acute and sub-acute toxicity study of Trikatu, a generic herbal formulation of Indian system of medicine, was carried out in Charles Foster (CF) rats for safety profiling. In acute toxicity experiment, Trikatu at 2,000 mg/kg body weight once orally was well tolerated by the experimental animals (both male and female) and no changes were observed in mortality, morbidity, gross pathology, gain in weight, vital organ weight, hematological (total white blood cells (WBC) and red blood cells (RBC) count), biochemical parameters such as serum creatinine, serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), serum lipid profile and tissue biochemical parameters such as reduced glutathione and malonaldehyde content as oxidative stress markers. In sub-acute experiment, Trikatu was administered at 5, 50 and 300 mg/kg body weight once daily for 28 days in female CF rats, and non-significant changes were found in most of the parameters studied such as acute experiment except significant increase in low density lipoprotein (LDL) cholesterol level at 50 and 300 mg/kg body weight, decrease in high density lipoprotein (HDL) cholesterol level at 300 mg/kg body weight, increase in SGPT activity at 50 mg/kg body weight and decrease in WBC count at 300 mg/kg body weight on 28(th) day post treatment.
authors.affiliation: Genetic Resources and Biotechnology Division, Central Institute of Medicinal and Aromatic Plants (CSIR). chandapt@gmail.com
authors.forename: Debabrata
authors.initials: D
authors.lastname: Chanda
authors.forename: Karuna
authors.initials: K
authors.lastname: Shanker
authors.forename: Anirban
authors.initials: A
authors.lastname: Pal
authors.forename: Suaib
authors.initials: S
authors.lastname: Luqman
authors.forename: Dnyaneshwar Umrao
authors.initials: DU
authors.lastname: Bawankule
authors.forename: Dayanandan
authors.initials: D
authors.lastname: Mani
authors.forename: Mahendra Pandurang
authors.initials: MP
authors.lastname: Darokar
mesh_terms: D000284:Administration, Oral; D000410:Alanine Transaminase / Q000096:biosynthesis / Q000187:drug effects; D000470:Alkaloids / Q000737:chemistry / Q000633:toxicity; D000475:Alkenes / Q000737:chemistry / Q000633:toxicity*; D000818:Animals; D052117:Benzodioxoles / Q000737:chemistry / Q000633:toxicity; D001835:Body Weight / Q000187:drug effects / Q000502:physiology; D008076:Cholesterol, HDL / Q000037:antagonists & inhibitors / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004353:Drug Evaluation, Preclinical; D005260:Female; D020939:Zingiber officinale / Q000737:chemistry; D005978:Glutathione / Q000096:biosynthesis / Q000187:drug effects; D008077:Lipoproteins, LDL / Q000096:biosynthesis / Q000187:drug effects; D008297:Male; D008515:Medicine, Ayurvedic; D009043:Motor Activity / Q000187:drug effects; D031701:Piper / Q000737:chemistry; D010880:Piperidines / Q000737:chemistry / Q000633:toxicity*; D028321:Plant Preparations / Q000737:chemistry / Q000494:pharmacology*; D053284:Polyunsaturated Alkamides / Q000737:chemistry / Q000633:toxicity; D051381:Rats; D011919:Rats, Inbred Strains; D012737:Sex Factors; D012894:Sleep Stages; D013997:Time Factors; D023382:Toxicity Tests, Acute / Q000379:methods
chemical_list: D000470:Alkaloids; D000475:Alkenes; D052117:Benzodioxoles; D008076:Cholesterol, HDL; D008077:Lipoproteins, LDL; D010880:Piperidines; D028321:Plant Preparations; D053284:Polyunsaturated Alkamides; C540456:trikatu; D000410:Alanine Transaminase; D005978:Glutathione; C008922:piperine