Intervention of Ayurvedic drugattenuates the metabolic alterations in hypertriglyceridemia: a pilot clinical trial.
J Diabetes Metab Disord. 2020 Dec ;19(2):1367-1379. Epub 2020 Oct 16. PMID: 33520840
Purpose: Hypertriglyceridemia (HG) is an independent risk factor with more prevalence than hypercholesterolemia and its attributes to cardiovascular disease (CVD) and pancreatitis. Hence, it becomes imperative to search for new triglyceride (TG) lowering agents.(TC) is a well-known Ayurvedic drug and a rich source of protoberberine alkaloids hence can contribute to TG lowering without side effects. Hence, to explore the therapeutic efficacy of T. cordifolia and its effects on biochemistry and metabolome in the patients of hyper-triglyceridemia, clinical trials were conducted.
Methods: Patients (n = 24) with hypertriglyceridemia were randomized into two groups to receive T. cordifolia(TCE) (3.0 g/per day) and metformin (850 mg/day) for 14 days having>300 mg/dl triglyceride level and cholesterol in the range of 130-230 mg/dl. Lipid profiles of blood samples were analyzed. Urine samples were subjected to HPLC-QTOF-MS to quantify oxidative damage and abnormal metabolic regulation.
Results: Intervention with TCE reduced the triglyceride, LDL, and VLDL levels to 380.45 ± 17.44, 133.25 ± 3.18, and 31.85 ± 5.88 mg/dL and increased the HDL to 47.50 ± 9.05 mg/dL significantly (p < 0.05) in the HG patients after 14 days treatment. TCE dosage potently suppressed the inflammatory and oxidative stress marker's i.e. levels of isoprostanes significantly (p < 0.01). Qualitative metabolomics approach i.e. PCA and PLS-DA showed significant alterations (p < 0.05) in the levels of 40 metabolites in the urine samples from different groups.
Conclusion: TCE administration depleted the levels of markers of HG i.e. VLDL, TG, and LDL significantly. Metabolomics studies established that the anti-HG activity of TCE was due to its antioxidative potential and modulation of the biopterin, butanoate, amino acid, and vitamin metabolism.
Clinical trials registry: India (CTRI) registration no. CTRI- 2016-08-007187.