The synergetic effect of Bergamot and Cynara Cardunculus Extract on vascular inflammation and endothelial dysfunction in patients with Type 2 Diabetes and NAFLD: a double blind, randomized, placebo-controlled study.

utramed Scarl0 个研究点目标入组 80 人开始时间: 2019年11月4日最近更新: 2023年1月9日

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32670822/ (added 01/12/2022)

•1. Men or women = 18 years
•2. Written informed consent
•3. History of at least 12 months of type 2 diabetes mellitus
•4. History of at least 12 months of NAFLD with no excessive alcohol consumption (less than 20 g/day for men and 10 g/day for women)
•5. Fatty liver
•6. Hepato-renal index between 2.5 and 3.5

•1. Positive pregnancy test (ßHCG) performed at the selection visit or result not available, women who are pregnant, women who are breast-feeding, women of childbearing potential not using estro-progestative or progestative or intrauterine contraception, or women using estro-progestative or progestative or inteauterine contraception, but who consider stopping it during the planned duration of the study
•2. History of alcoholism or drug abuse
•3. Patients with viral or autoimmune liver disease
•4. Patients unlikely to co-operate in the study or to comply well with the treatment or with the study visits
•5. History of severe mental or psychiatric disorder, severe depression or history of severe depression, e.g. requiring an hospitalization or at high risk of suicide attempt
•6. Participation in another study at the same time or within the preceding 30 days

发起方

utramed Scarl