title: Short-term effect of G-400, polyherbal formulation in the management of hyperglycemia and hyperlipidemia conditions in patients with type 2 diabetes mellitus.
abstract: OBJECTIVE
  Salacia oblonga, Tinospora cordifolia, Emblica offinalis Gaertn, Curcuma longa and Gymnema sylvestre are Ayurvedic medicinal plants reported to lower plasma glucose levels in animal models. To our knowledge, however, no clinical validations of those extracts for efficacy have been. The aim of this study was to evaluate the effect of polyherbal combination in patients with type 2 diabetes mellitus.
  
  
  METHODS
  We screened 250 patients enrolled in a diabetes mellitus screening camp held at District Ayurvedic Hospital, Kottayam, Kerala, India. Of these, 89 patients diagnosed with type 2 diabetes mellitus and 50 healthy volunteers of similar age group were included in the study. Patients were treated with a polyherbal combination drug namely G-400 (1000 mg/d) for 8 wk with a follow-up of 2wk interval.
  
  
  RESULTS
  Fasting and postprandial blood glucose levels measured after 8 wk of G-400 treatment in patients were significantly lower. Indeed diabetic rats showed similar protection with G-400 administration. Furthermore, glycosylated hemoglobin, serum total cholesterol, both high- and low-density lipoprotein cholesterol, and triglycerides showed a significant improvement in G-400-administered patients. Toxicologic profile of the drug was assessed by analyzing the enzyme activities of alkaline phosphatase and alanine aminotransferase along with the concentration of blood urea nitrogen and creatinine in blood and found insignificant change compared with control.
  
  
  CONCLUSIONS
  Short-term supplementation of G-400 not only attenuates the hyperglycemia, but also acts as hypolipidemic agent in patients with diabetes. Further study should be done for the long-term effect of the drug in larger populations.
authors: Department of Medical Biochemistry, School of Medical Education, Mahatma Gandhi University, Kottayam, India; School of Chemical and Biotechnology, SASTRA University, Thanjavur, Tamil Nadu, India. Electronic address: kurian@scbt.sastra.edu.
authors: Gino A
authors: GA
authors: Kurian
authors: Department of Medical Biochemistry, School of Medical Education, Mahatma Gandhi University, Kottayam, India.
authors: V
authors: V
authors: Manjusha
authors: Department of Medical Biochemistry, School of Medical Education, Mahatma Gandhi University, Kottayam, India.
authors: Sunitha S
authors: SS
authors: Nair
authors: Department of Medical Biochemistry, School of Medical Education, Mahatma Gandhi University, Kottayam, India.
authors: Thomas
authors: T
authors: Varghese
authors: Amala Cancer Research Centre, Thrissur, Kottayam, India.
authors: Jose
authors: J
authors: Padikkala
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D019587:Dietary Supplements; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000494:pharmacology; D008055:Lipids / Q000097:blood; D019684:Magnoliopsida; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000960:Hypolipidemic Agents; D008055:Lipids; D010936:Plant Extracts
keywords: Ayurvedic medicine; Clinical trial; Poly herbal combination; Type 2 diabetes mellitus patients