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.

2020-07-02
Phytotherapy research : PTR 34(12)
- Usharani Pingali
- Deepasree Sukumaran
- Chandrasekhar Nutalapati

PubMed: 32618037
DOI: 10.1002/ptr.6771

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 60
Population: patients with type 2 diabetes
Methods: A prospective, randomized, double-blind, placebo-controlled clinical study; aqueous extract of T. chebula 250 and 500 mg versus placebo twice daily for 12 weeks
Blinding: Double-blind
Duration: 12 weeks
Funding: Unclear

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.

Research Insights

Haritaki→Improved Blood Lipid Profile
Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.
Effect
Beneficial
Effect size
Small
Dose
500 mg twice daily
Haritaki→Improved Vascular Endothelial Function
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%).
Effect
Beneficial
Effect size
Large
Dose
500 mg twice daily
Haritaki→Increased Glutathione Level
Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.
Effect
Beneficial
Effect size
Small
Dose
500 mg twice daily
Haritaki→Increased Nitric Oxide Level
Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.
Effect
Beneficial
Effect size
Small
Dose
500 mg twice daily
Haritaki→Reduced Glycosylated Hemoglobin
Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.
Effect
Beneficial
Effect size
Small
Dose
500 mg twice daily
Haritaki→Reduced High-Sensitivity C-Reactive Protein Level
Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.
Effect
Beneficial
Effect size
Small
Dose
500 mg twice daily
Haritaki→Reduced Malondialdehyde Level
Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.
Effect
Beneficial
Effect size
Small
Dose
500 mg twice daily