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
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 patie...
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Wolters Kluwer Medknow Publications
2018
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Online Access: | https://doi.org/10.4103/2221-1691.242288 https://doaj.org/article/a04c27f00b894abd8b998df3f29ab74a |
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ftdoajarticles:oai:doaj.org/article:a04c27f00b894abd8b998df3f29ab74a 2023-05-15T15:17:07+02:00 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 Amit Kandhare Uday Phadke Abhay Mane Prasad Thakurdesai Sunil Bhaskaran 2018-01-01T00:00:00Z https://doi.org/10.4103/2221-1691.242288 https://doaj.org/article/a04c27f00b894abd8b998df3f29ab74a EN eng Wolters Kluwer Medknow Publications http://www.apjtb.org/article.asp?issn=2221-1691;year=2018;volume=8;issue=9;spage=446;epage=455;aulast=Kandhare https://doaj.org/toc/2221-1691 2221-1691 doi:10.4103/2221-1691.242288 https://doaj.org/article/a04c27f00b894abd8b998df3f29ab74a Asian Pacific Journal of Tropical Biomedicine, Vol 8, Iss 9, Pp 446-455 (2018) add-on therapy dietary supplement glycaemic control hba1c standardized fenugreek seed extract type 2 diabetes Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 article 2018 ftdoajarticles https://doi.org/10.4103/2221-1691.242288 2022-12-31T12:59:39Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Asian Pacific Journal of Tropical Biomedicine 8 9 446 |
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add-on therapy dietary supplement glycaemic control hba1c standardized fenugreek seed extract type 2 diabetes Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 |
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add-on therapy dietary supplement glycaemic control hba1c standardized fenugreek seed extract type 2 diabetes Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 Amit Kandhare Uday Phadke Abhay Mane Prasad Thakurdesai Sunil Bhaskaran 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 |
topic_facet |
add-on therapy dietary supplement glycaemic control hba1c standardized fenugreek seed extract type 2 diabetes Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Amit Kandhare Uday Phadke Abhay Mane Prasad Thakurdesai Sunil Bhaskaran |
author_facet |
Amit Kandhare Uday Phadke Abhay Mane Prasad Thakurdesai Sunil Bhaskaran |
author_sort |
Amit Kandhare |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Wolters Kluwer Medknow Publications |
publishDate |
2018 |
url |
https://doi.org/10.4103/2221-1691.242288 https://doaj.org/article/a04c27f00b894abd8b998df3f29ab74a |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Asian Pacific Journal of Tropical Biomedicine, Vol 8, Iss 9, Pp 446-455 (2018) |
op_relation |
http://www.apjtb.org/article.asp?issn=2221-1691;year=2018;volume=8;issue=9;spage=446;epage=455;aulast=Kandhare https://doaj.org/toc/2221-1691 2221-1691 doi:10.4103/2221-1691.242288 https://doaj.org/article/a04c27f00b894abd8b998df3f29ab74a |
op_doi |
https://doi.org/10.4103/2221-1691.242288 |
container_title |
Asian Pacific Journal of Tropical Biomedicine |
container_volume |
8 |
container_issue |
9 |
container_start_page |
446 |
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