Single arm, non-blinded study assessing the effect of the novel herbal composition SR2004 on the primary endpoint haemoglobin A1c and secondary endpoints fasting blood glucose, and lipid profile in type 2 diabetic patients recruited in Israel over a 12 week period

Maccabi Healthcare Services0 个研究点目标入组 119 人开始时间: 2017年6月12日最近更新: 2023年7月25日

适应症

试验速览

2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30271713/ (added 11/07/2023)

•1. Confirmed diagnosis of T2DM and any combination of oral hypoglycemics and/or insulin
•2. HbA1c 7.1–10% in the last 6 months
•3. Body mass index (BMI) <45 kg/m2
•4. Ability to provide written informed consent
•5. No participation in an investigational drug study (or use of herbal supplementation) within the prior 30 days
•6. Women of childbearing age are required to have a negative pregnancy test and use contraception for the duration of the trial
•7. Aged 18 years and over

•1. Type 1 diabetes mellitus
•2. Treatment with the drugs acarbose or rosiglitazone for more than 2 weeks in the last six months
•3. Concomitant malignancy
•4. Concomitant heart failure grade 2-4 (American Heart Association)
•5. Liver dysfunction (alanine aminotransferase or aspartate aminotransferase more than 3 times upper limit of normal values) 6. Renal failure (serum creatinine more than 1.3 times upper limit normal for women and 1.4 for men)
•7. History of severe psychiatric illness on medication

发起方

Maccabi Healthcare Services