Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink

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 year.At 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 trend.Long term dyslipidemia will increase the incidence rate and mortality of atherosclerotic diseases.Tibetan 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 aspects.At 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.

Timeline

Start

2024-10-01

Primary completion

2025-08-08

Completion

2025-08-08

Publications

• Background Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
• Background Zenych A, Fournier L, Chauvierre C. Nanomedicine progress in thrombolytic therapy. Biomaterials. 2020 Nov;258:120297. doi: 10.1016/j.biomaterials.2020.120297. Epub 2020 Aug 6.
• Background Li Z, Lin L, Wu H, Yan L, Wang H, Yang H, Li H. Global, Regional, and National Death, and Disability-Adjusted Life-Years (DALYs) for Cardiovascular Disease in 2017 and Trends and Risk Analysis From 1990 to 2017 Using the Global Burden of Disease Study and Implications for Prevention. Front Public Health. 2021 Oct 29;9:559751. doi: 10.3389/fpubh.2021.559751. eCollection 2021.
• Background writing committee of the report on cardiovascular health and diseases in china. Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary. Biomed Environ Sci. 2022 Jul 20;35(7):573-603. doi: 10.3967/bes2022.079.
• Background Adhyaru BB, Jacobson TA. Safety and efficacy of statin therapy. Nat Rev Cardiol. 2018 Dec;15(12):757-769. doi: 10.1038/s41569-018-0098-5.
• Background Colantonio LD, Huang L, Monda KL, Bittner V, Serban MC, Taylor B, Brown TM, Glasser SP, Muntner P, Rosenson RS. Adherence to High-Intensity Statins Following a Myocardial Infarction Hospitalization Among Medicare Beneficiaries. JAMA Cardiol. 2017 Aug 1;2(8):890-895. doi: 10.1001/jamacardio.2017.0911.
• Background Sattar N. Statins and diabetes: What are the connections? Best Pract Res Clin Endocrinol Metab. 2023 May;37(3):101749. doi: 10.1016/j.beem.2023.101749. Epub 2023 Feb 15.
• Background Khatiwada N, Hong Z. Potential Benefits and Risks Associated with the Use of Statins. Pharmaceutics. 2024 Feb 1;16(2):214. doi: 10.3390/pharmaceutics16020214.
• Background Ward NC, Watts GF, Eckel RH. Statin Toxicity. Circ Res. 2019 Jan 18;124(2):328-350. doi: 10.1161/CIRCRESAHA.118.312782.
• Background Bakker-Arkema RG, Davidson MH, Goldstein RJ, Davignon J, Isaacsohn JL, Weiss SR, Keilson LM, Brown WV, Miller VT, Shurzinske LJ, Black DM. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA. 1996 Jan 10;275(2):128-33.
• Background Ginsberg HN, Packard CJ, Chapman MJ, Boren J, Aguilar-Salinas CA, Averna M, Ference BA, Gaudet D, Hegele RA, Kersten S, Lewis GF, Lichtenstein AH, Moulin P, Nordestgaard BG, Remaley AT, Staels B, Stroes ESG, Taskinen MR, Tokgozoglu LS, Tybjaerg-Hansen A, Stock JK, Catapano AL. Triglyceride-rich lipoproteins and their remnants: metabolic insights, role in atherosclerotic cardiovascular disease, and emerging therapeutic strategies-a consensus statement from the European Atherosclerosis Society. Eur Heart J. 2021 Dec 14;42(47):4791-4806. doi: 10.1093/eurheartj/ehab551.
• Background Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
• Background Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.
• Background Yannakoulia M, Scarmeas N. Diets. N Engl J Med. 2024 Jun 13;390(22):2098-2106. doi: 10.1056/NEJMra2211889. No abstract available.
• Background Delgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Fuentes F, Garcia-Rios A, Ortiz-Morales AM, Gonzalez-Requero AI, Perez-Caballero AI, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Lopez-Segura F, Badimon L, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.

Drugs

Indications