title: Evaluation of subacute toxicity of methanolic/aqueous preparation of aerial parts of O. sanctum in Wistar rats: Clinical, haematological, biochemical and histopathological studies.
abstract: BACKGROUND
  Ocimum sanctum, commonly known as Holy Basil or Tulsi has been used in Ayurveda as a demulcent, stimulant, expectorant; in the treatment of bronchitis, skin infections, malaria, diarrhoea, dysentery, arthritis, gastric and inflammatory disorders. We have previously shown that methanolic/aqueous extract of O. sanctum did not induce genotoxicity and other toxic effects in acute oral toxicity study. In the present report, we have performed sub-acute toxicity of methanolic/aqueous preparation of O. sanctum in Wistar rats to evaluate whether it induced any chronic toxic effects.
  
  
  METHODS
  In subacute toxicity study, animals received O. sanctum extract (OSE) by oral gavage at the doses of 250, 500 and 1000 mg/kg/day (n=5/group/sex) for 28 days. At the end of the study, the animals were sacrificed and evaluated for the effect of OSE on clinical, haematological, biochemical and histopathological parameters.
  
  
  RESULTS
  The rats treated with OSE did not show any change in body weight, food and water consumption, motor activity, sensory reactivity and foot splay measurements. There were no significant changes in haematological, pathological and biochemical parameters; and histopathology of tissues (liver, kidney, spleen, heart, and testis/ovary) among rats of either sex. OSE at a dose of 1000 mg/kg showed significant increase of Mean corpuscular hemoglobin (MCH) (19.8 ± 0.8; 18.7 ± 0.5) and mean corpuscular hemoglobin concentration (MCHC) (41.8 ± 1.1; 39.3 ± 0.7) in male and female rats in comparison to their respective controls (MCH: 17.7 ± 0.3; 17.4 ± 0.3; MCHC: 37.8 ± 0.5; 36.1 ± 0.2). Urine parameters (appearance, blood, nitrate, leucocyte, glucose, ketone, pH, protein and specific gravity) in both the male and female rats were comparable to their respective controls. In addition, no changes were observed in the vital organs of rats at macroscopic and microscopic levels.
  
  
  CONCLUSIONS
  Our results showed that oral administration of OSE was not toxic to male and female Wistar rats upto the highest dose tested, thereby suggesting its clinical usefulness.
authors.affiliation: Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth University Medical College Campus, Katraj-Dhankawadi, Pune 411043, India.
authors.forename: P
authors.initials: P
authors.lastname: Raina
authors.affiliation: Natural Remedies Pvt. Ltd., 5B Veerasandra Industrial Area, 19th KM Stone, Hosur Road, Electronic City Post, Bangalore 560100, Karnataka, India.
authors.forename: C V
authors.initials: CV
authors.lastname: Chandrasekaran
authors.affiliation: Natural Remedies Pvt. Ltd., 5B Veerasandra Industrial Area, 19th KM Stone, Hosur Road, Electronic City Post, Bangalore 560100, Karnataka, India.
authors.forename: M
authors.initials: M
authors.lastname: Deepak
authors.affiliation: Natural Remedies Pvt. Ltd., 5B Veerasandra Industrial Area, 19th KM Stone, Hosur Road, Electronic City Post, Bangalore 560100, Karnataka, India.
authors.forename: A
authors.initials: A
authors.lastname: Agarwal
authors.affiliation: Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth University Medical College Campus, Katraj-Dhankawadi, Pune 411043, India. Electronic address: ruchika.kaulghanekar@gmail.com.
authors.forename: K-G
authors.initials: KG
authors.lastname: Ruchika
mesh_terms: D000818:Animals; D004909:Erythrocyte Indices / Q000187:drug effects; D005260:Female; D008297:Male; D000432:Methanol / Q000737:chemistry; D031339:Ocimum; D035261:Plant Components, Aerial / Q000737:chemistry; D010936:Plant Extracts / Q000633:toxicity*; D017208:Rats, Wistar; D012997:Solvents / Q000737:chemistry; D059551:Toxicity Tests, Subacute
chemical_list: D010936:Plant Extracts; D012997:Solvents; D000432:Methanol
keywords: Methanolic/aqueous extract; O. sanctum; Subacute toxicology