Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551298
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
About 179 million people die from cardiovascular disease each year accounting for approximately 31 of global deaths It is expected that this number will exceed 236 million by 2030 and the economic burden caused by this disease is increasing year by yearAt present the number of people suffering from cardiovascular diseases in China is as high as 330 million and the mortality rate accounts for more than 40 of the total deaths caused by diseases and is in a continuous upward trendLong term dyslipidemia will increase the incidence rate and mortality of atherosclerotic diseasesTibetan tea contains catechins caffeine amino acids vitamins and various mineral components which have significant effects in reducing cholesterol improving carbohydrate metabolism lowering blood sugar losing weight softening human blood vessels and other aspectsAt present there are no research reports on the lipid-lowering effect of Mongolian Gongzi Tibetan Tea Special Drink and most studies on the lipid-lowering effect of Tibetan Tea are animal experiments or clinical observational studies Therefore this study intends to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Mongolian Gongzi Tibetan Tea Special Drink in patients with hyperlipidemia
Detailed Description:
Every year approximately 179 million people die from cardiovascular diseases accounting for about 31 of global deaths This number is expected to exceed 236 million by 2030 and the economic burden of these diseases is increasing year by year Currently in China there are up to 330 million people suffering from cardiovascular diseases with the mortality rate exceeding 40 of disease-related deaths and continuing to rise Chronic dyslipidemia increases the incidence and mortality of atherosclerotic cardiovascular disease ASCVD Hyperlipidemia refers to elevated levels of one or more lipids in the plasma due to abnormal lipid metabolism or transport leading to deposition in the vascular endothelium and causing damage to the body This condition manifests as hypercholesterolemia hypertriglyceridemia or low high-density lipoprotein cholesterol Additionally this disease is closely related to the onset of stroke diabetes hypertension fatty liver and other conditions In recent years the incidence of hyperlipidemia has significantly increased due to changes in lifestyle especially dietary habits The atherosclerotic cardiovascular diseases caused by hyperlipidemia are often characterized by high incidence severe harm and rapid disease progression Hyperlipidemia is becoming an invisible killer of human health
Statins are the most recommended medication for ASCVD due to their significant effect in lowering low-density lipoprotein cholesterol with strong evidence supporting their use However the side effects of statins have not been fully resolved Among patients receiving statin treatment 10-29 may experience statin-related muscle symptoms such as cramps myalgia weakness immune-mediated necrotizing myopathy and more rarely rhabdomyolysis Medium-intensity statins may increase the risk of type 2 diabetes by approximately 11 while high-intensity statins might increase the risk by 20 or more Early clinical trials of statins showed that up to 2 of patients experienced elevated transaminases and the impact on renal function remains controversial Additionally statin-related adverse events include cataracts gastrointestinal issues effects on the genitourinary system gynecomastia and reproductive issues Balancing the benefits and risks of statin therapy is a crucial challenge for all cardiovascular doctors
Tea is one of the worlds three major non-alcoholic beverages and has been used both as a food and medicine for over 5000 years Yaan Tibetan tea is a local specialty black tea named after its primary production in Yaan Sichuan Province and historically popular in Tibetan areas such as Tibet and Qinghai Tibetan tea contains catechins caffeine amino acids vitamins and various minerals particularly rich in tea pigments tea polysaccharides and tea saponins Besides the general benefits of tea such as anti-cancer anti-aging antioxidant anti-bacterial and anti-radiation effects it has significant effects on lipid reduction improving carbohydrate metabolism lowering blood sugar weight loss and softening blood vessels Meng Gongzi Tibetan Tea Special Drink is made from Tibetan tea using modern green separation and purification technology to extract and concentrate key functional components like tea polysaccharides and tea pigments It adds sorbitol which is indigestible and harmless to the human body to enhance palatability and is produced using instant sterilization and hot filling technology without preservatives strictly according to GBT21733 standards resulting in a convenient drink with high tea pigment and polysaccharide content
Currently there is no research report on Meng Gongzi Tibetan Tea Special Drink and studies on the lipid-lowering effects of Tibetan tea are mostly animal experiments or observational studies Therefore this study aims to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Meng Gongzi Tibetan Tea Special Drink for patients with hyperlipidemia
Statins are the most recommended medication for ASCVD due to their significant effect in lowering low-density lipoprotein cholesterol with strong evidence supporting their use However the side effects of statins have not been fully resolved Among patients receiving statin treatment 10-29 may experience statin-related muscle symptoms such as cramps myalgia weakness immune-mediated necrotizing myopathy and more rarely rhabdomyolysis Medium-intensity statins may increase the risk of type 2 diabetes by approximately 11 while high-intensity statins might increase the risk by 20 or more Early clinical trials of statins showed that up to 2 of patients experienced elevated transaminases and the impact on renal function remains controversial Additionally statin-related adverse events include cataracts gastrointestinal issues effects on the genitourinary system gynecomastia and reproductive issues Balancing the benefits and risks of statin therapy is a crucial challenge for all cardiovascular doctors
Tea is one of the worlds three major non-alcoholic beverages and has been used both as a food and medicine for over 5000 years Yaan Tibetan tea is a local specialty black tea named after its primary production in Yaan Sichuan Province and historically popular in Tibetan areas such as Tibet and Qinghai Tibetan tea contains catechins caffeine amino acids vitamins and various minerals particularly rich in tea pigments tea polysaccharides and tea saponins Besides the general benefits of tea such as anti-cancer anti-aging antioxidant anti-bacterial and anti-radiation effects it has significant effects on lipid reduction improving carbohydrate metabolism lowering blood sugar weight loss and softening blood vessels Meng Gongzi Tibetan Tea Special Drink is made from Tibetan tea using modern green separation and purification technology to extract and concentrate key functional components like tea polysaccharides and tea pigments It adds sorbitol which is indigestible and harmless to the human body to enhance palatability and is produced using instant sterilization and hot filling technology without preservatives strictly according to GBT21733 standards resulting in a convenient drink with high tea pigment and polysaccharide content
Currently there is no research report on Meng Gongzi Tibetan Tea Special Drink and studies on the lipid-lowering effects of Tibetan tea are mostly animal experiments or observational studies Therefore this study aims to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Meng Gongzi Tibetan Tea Special Drink for patients with hyperlipidemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None