Effect of an aqueous extract of Terminalia chebula on endothelial dysfunction, systemic inflammation, and lipid profile in type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical study

Phytother Res. 2020 Dec;34(12):3226-3235. doi: 10.1002/ptr.6771. Epub 2020 Jul 2.

Abstract

Endothelial dysfunction is a crucial complication in type 2 diabetic patients, related to cardiovascular risk. Terminalia chebula (TC), a traditional ayurvedic herb, is known for its antioxidant and antihyperlipidemic activity. A prospective, randomized, double-blind, placebo-controlled clinical study was undertaken to evaluate the effects of an aqueous extract of T. chebula 250 and 500 mg versus placebo on endothelial dysfunction and biomarkers of oxidative stress in type 2 diabetic patients. A total of 60 eligible patients were randomized to receive either T. chebula 250 mg, T. chebula 500 mg, or placebo twice daily for 12 weeks. The subjects were assessed based on the endothelial function, the levels of nitric oxide, malondialdehyde, glutathione, high sensitivity C-reactive protein, glycosylated hemoglobin, and lipid profile at baseline and after 12 weeks of treatment. Treatment with T. chebula 250 mg and T. chebula 500 mg for 12 weeks significantly improved the endothelial function (reflection index) compared to placebo (absolute changes: - T. chebula 250: -2.55 ± 1.82% vs. T. chebula 500: -5.21 ± 2.41% vs. placebo: 1.40 ± 2.11%). Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo. In conclusion, T. chebula (especially, 500 mg BID dose) significantly minimized the cardiovascular risk factors in patients with type 2 diabetes compared to placebo.

Keywords: Terminalia chebula; endothelial dysfunction; lipid profile; oxidative stress; type 2 diabetes.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antioxidants / chemistry
  • Antioxidants / pharmacology
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / metabolism
  • Diabetes Mellitus, Type 2 / physiopathology
  • Diabetic Angiopathies / drug therapy
  • Diabetic Angiopathies / physiopathology
  • Double-Blind Method
  • Endothelium, Vascular / drug effects
  • Endothelium, Vascular / physiopathology
  • Female
  • Humans
  • India
  • Inflammation / drug therapy
  • Inflammation / etiology
  • Inflammation / metabolism
  • Lipid Metabolism / drug effects
  • Lipids / blood
  • Male
  • Middle Aged
  • Nitric Oxide / metabolism
  • Oxidative Stress / drug effects
  • Phytotherapy
  • Placebos
  • Plant Extracts / pharmacology
  • Plant Extracts / therapeutic use*
  • Terminalia / chemistry*
  • Water / chemistry

Substances

  • Antioxidants
  • Lipids
  • Placebos
  • Plant Extracts
  • Water
  • Nitric Oxide