Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494683
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Efficacy and Safety of Pueraria Lobata Radix as an Adjuvant Treatment for Type 2 Diabetes Mellitus
Sponsor:
Jiangxi University of Traditional Chinese Medicine
Organization:
Jiangxi University of Traditional Chinese Medicine
Study Overview
Official Title:
Efficacy and Safety of Pueraria Lobata Radix as an Adjuvant Treatment for Type 2 Diabetes Mellitus A Multicenter Randomized Double-blinded Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As a dietary herb pueraria lobata radix PLR has been showed to have hypoglycemic effects in animal experiments However there is currently a lack of evidence from randomized controlled trials Therefore this randomized double-blind placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus T2DM
Detailed Description:
As a dietary herb pueraria lobata radix PLR has been showed to have hypoglycemic effects in animal experiments However there is currently a lack of evidence from randomized controlled trials Therefore this randomized double-blind placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus T2DM
T2DM is the most prevalent chronic metabolic disease It has been noted in clinical practice that the limitations of conventional treatment methods such as secondary failure and adverse reactions continue to pose challenges for patients in managing their blood glucose levels preventing them from achieving optimal glycemic control goals Therefore it is essential to search for more effective and safe complementary medications
PLR Chinese name Ge Gen is the dried root of the leguminous plant kudzu Pueraria lobata Willd Ohwi In China and other East Asian countries PLR has been widely used to treat metabolic diseases including T2DM The chemical components of PLR include isoflavones triterpenes saponins polysaccharides coumarin compounds and alkaloids with isoflavones being the primary active ingredients of PLR Multiple animal studies have shown that the main active components in isoflavones such as puerarin daidzein and genistein effectively increase serum insulin concentrations lower blood glucose levels and improve insulin resistance in diabetic mice Puerarin injection has been widely used in China for the treatment of diabetes and its complications
PLR is classified as a medicinal and edible herb according to Chinese regulations demonstrating good safety with no reports of adverse reactions from long-term consumption in practice However there is currently a lack of randomized controlled trial evidence on the use of PLR for assisting in glycemic management Therefore this study aims to conduct a randomized controlled trial to evaluate the efficacy and safety of daily PLR treatment for adjunctive management of T2DM
T2DM is the most prevalent chronic metabolic disease It has been noted in clinical practice that the limitations of conventional treatment methods such as secondary failure and adverse reactions continue to pose challenges for patients in managing their blood glucose levels preventing them from achieving optimal glycemic control goals Therefore it is essential to search for more effective and safe complementary medications
PLR Chinese name Ge Gen is the dried root of the leguminous plant kudzu Pueraria lobata Willd Ohwi In China and other East Asian countries PLR has been widely used to treat metabolic diseases including T2DM The chemical components of PLR include isoflavones triterpenes saponins polysaccharides coumarin compounds and alkaloids with isoflavones being the primary active ingredients of PLR Multiple animal studies have shown that the main active components in isoflavones such as puerarin daidzein and genistein effectively increase serum insulin concentrations lower blood glucose levels and improve insulin resistance in diabetic mice Puerarin injection has been widely used in China for the treatment of diabetes and its complications
PLR is classified as a medicinal and edible herb according to Chinese regulations demonstrating good safety with no reports of adverse reactions from long-term consumption in practice However there is currently a lack of randomized controlled trial evidence on the use of PLR for assisting in glycemic management Therefore this study aims to conduct a randomized controlled trial to evaluate the efficacy and safety of daily PLR treatment for adjunctive management of T2DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None