Add-on therapy of herbal formulation rich in standardized fenugreek seed extract in type 2 diabetes mellitus patients with insulin therapy: An efficacy and safety study
Journal Title: Asian Pacific Journal of Tropical Biomedicine - Year 2018, Vol 8, Issue 9
Abstract
Objective: To assess the safety and efficacy of herbal formulation rich in standardized fenugreek seed extract (IND-2) add-on therapy in type 2 diabetes mellitus (T2DM) patients who were on insulin treatment in prospective, single arm, open-label, uncontrolled, multicentre trial. Methods: T2DM patients (n=30) with aged 18-80 years who were stabilized on insulin treatment with fasting blood sugar (FBS) level between 100-140 mg/dL received IND-2 capsules (700 mg, thrice a day) for 16 weeks. The primary endpoints were an assessment of FBS at week 2, 4, 6, 8, 12 and 16. Secondary end-points include post-prandial blood sugar level, glycosylated Hb (HbA1c), reduction in the dose of insulin and number of hypoglycemic attacks, and improvement in lipid profile at various weeks. Safety and adverse events (AEs) were also assessed during the study. Results: Study was completed in twenty T2DM patients, and there was no significant reduction in FBS and post-prandial blood sugar level after addon therapy of IND-2. However, add-on therapy of IND-2 significantly reduced (P<0.01) the HbA1c values, requirements of insulin and hypoglycemic events as compared with baseline. Total cholesterol, high-density lipoproteins-cholesterol, and low-density lipoprotein-cholesterol levels were significantly increased (P<0.01) after IND-2 add-on therapy. Body weight and safety outcomes did not differ significantly in IND-2 add-on therapy group at week 16. Additionally, add-on therapy of IND-2 did not produce any serious adverse events. Conclusions: The results of present investigation suggest that add-on therapy of IND-2 with insulin in T2DM patients improves glycaemic control through a decrease in levels of HbA1c and number of insulin doses needed per day without an increase in body weight and risk of hypoglycemia. Thus, IND-2 may provide a safe and well-tolerated add-on therapy option for the management of T2DM.
Authors and Affiliations
Amit Kandhare, Uday Phadke, Abhay Mane, Prasad Thakurdesai, Sunil Bhaskaran
Keywords
Related Articles
- EP ID EP405852
- DOI 10.4103/2221-1691.242288
- Views 61
- Downloads 0
Reduction of hydrogen peroxide–induced erythrocyte damage by Carica papaya leaf extract
Objective To investigate the in vitro antioxidant potential of Carica papaya (C. papaya) leaf extract and its effect on hydrogen peroxide-induced erythrocyte damage assessed by haemolysis and lipid peroxidation. Method...
Effects of the Syzygium aromaticum L. extract on antioxidation and inhibition of matrix metalloproteinase in human dermal fibroblast
Objective: To investigate cosmetic potential of Syzygium aromaticum L. (S. aromaticum L.) and to determine its antioxidant and anti-wrinkling effects. Methods: Using high-performance liquid chromatography, eugenol compon...
Molecular study of HCV detection, genotypes and their routes of transmission in North West Frontier Province, Pakistan
Objective To determine hepatitis C virus (HCV) genotypes and explore the associated risk factors in chronic HCV patients. Methods A total of 116 patients with chronic hepatitis C were subjected to polymerase chain rea...
Physicochemical properties, antioxidant and anti-inflammatory activities of coumarin-carbonodithioate hybrids
Objective: To study physicochemical properties, antioxidant and anti-inflammatory activities of coumarin-carbonodithioate hybrids. Methods: The substituted 4-bromomethyl coumarins were synthesized in first step by the cy...
Construction and expression of a synthetic gene encoding nonstructural glycoprotein NS1 of dengue 2 virus in Pichia pastoris
Objectives: To express and characterize NS1 of Indonesian-specific DENV2 virus in Pichia pastoris (P. pastoris). Methods: A codon optimized synthetic gene derived from the DENV-2 NS1 amino acid sequences was synthesized...