28-Day Repeated Dose Oral Toxicity of a Herbal Mixture Dia-2, Containing Standardized Extracts of Allium Sativum and Lagerstroemia Speciosa In Sprague Dawley Rats

Authors

  • KS. Kesavanarayanan Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • P. Kalaivani Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • G.Ramakrishnan Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • S.Sathiya Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • V.Ranju Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • R.Jyothipriya Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • Chinnasamy Selvakkumar Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • C.Saravanababu Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • J.venkhatesh Centre for Toxicology and Developmental Research, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India
  • R.Ilavarasa Captain Srinivasa Murti Drug Research Institute for Ayurveda and Siddha, Arumbakkam, Chennai 600 106, Tamilnadu, India
  • S.Kavimani Department of Pharmacology, Division of Pharmacy, Mother Therasa Institute of Health Sciences, Pondicherry, India
  • D Prathiba Department of Pathology, Sri Ramachandra University, Chennai 600 116, Tamilnadu, India.

Keywords:

Allium sativum, Lagerstroemia speciosa, diabetes mellitus, repeated oral toxicity, herbal formulation

Abstract

Allium sativum [ASE] and Lagerstroemia speciosa [LSE] are widely used in folk medicine as a medication for diabetes. DIA-2 is a polyherbal antidiabetic formulation containing fixed combination [1:1 w/w] of standardized aqueous extracts of Allium sativum bulbs containing 1.1 % alliin w/w and 40 % hydroalcholic extract of Lagerstroemia speciosa leaves containing 1.28% w/w corosolic acid. Earlier studies in our laboratories have demonstrated the oral safety of DIA-2 on acute oral exposure to female Sprague Dawley [SD] rats and the antidiabetic activity of DIA-2 in high-fat diet fed/streptozotocin-induced diabetic rats. The ingredients of DIA-2 have long history safety but however, there is little toxicological information regarding the oral safety on repeated exposure of ASE and LSE when given as a combined mixture. The present study evaluated the repeated oral toxicity of DIA-2 in both the sexes of SD rats. Rats were treated orally once with 62.5, 125, 250 mg/kg body weight, and animals were observed till the 28 days of study. On repeated oral administration, DIA-2 showed did not exhibit any clinical signs of toxicity, mortality, significant change in food, water consumption, body weight, mortality, clinical chemistry, hematology, organ weight, gross pathology and histopathology when varying doses of the DIA-2 were administered orally once daily for a period of 28 days. The NOAEL [No Observed Adverse Effect Level] of DIA-2 in this study was identified to be greater than 250 mg/kg/day. The results from the study suggest that there are no toxicologically significant effects on 28 day repeated oral administration of DIA-2 and the data also provide satisfactory preclinical evidence on its oral safety to support its use as a therapeutic agent in the treatment of diabetes mellitus.

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Published

30-09-2012

How to Cite

1.
KS. Kesavanarayanan, P. Kalaivani, G.Ramakrishnan, S.Sathiya, V.Ranju, R.Jyothipriya, Chinnasamy Selvakkumar, C.Saravanababu, J.venkhatesh, R.Ilavarasa, S.Kavimani, D Prathiba. 28-Day Repeated Dose Oral Toxicity of a Herbal Mixture Dia-2, Containing Standardized Extracts of Allium Sativum and Lagerstroemia Speciosa In Sprague Dawley Rats. ijp [Internet]. 2012 Sep. 30 [cited 2024 Dec. 6];4(3):340-5. Available from: https://ijp.arjournals.org/index.php/ijp/article/view/184

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