Please use this identifier to cite or link to this item: http://hdl.handle.net/10603/234494
Title: A Randomized Open Label Active Control Phase IV Clinical Study Evaluating Efficacy and Safety of Resveratrol As an Adjuvant Therapy in Patients with Diabetes Dyslipidemia and Hypertension
Researcher: Ojha Rakesh Upendranath
Guide(s): Vyas Bhavin
Keywords: Clinical Pharmacy Disease
University: Uka Tarsadia University
Completed Date: 2018
Abstract: OBJECTIVES: The aim of this study was to investigate the efficacy and safety of resveratrol as an adjuvant therapy in newly diagnosed type 2 diabetes mellitus (T2DM) patients with borderline dyslipidemia (Diabetes study), in newly diagnosed dyslipidaemia patients (dyslipidemia study) and newly diagnosed hypertensive patients (hypertension study). newlineSUBJECTS AND METHODS: In this randomized active-controlled study, T2DM patients (male/female) aged 20-65 years with borderline dyslipidemia (hypolipidemic naïve patients) were randomized to receive glimepiride 2mg or glimepiride 2mg plus resveratrol 1 gram daily for 12 months (for Diabetes study). In dyslipidemia study, dyslipidaemia patients (male/female) aged 20-65 years were randomized to receive (1:1) either atorvastatin (10 mg daily) or atorvastatin (10 mg daily) plus resveratrol (500mg twice daily) as adjuvant therapy for 12 months. In hypertension study, patients with Stage I hypertension (SBP 140 159 mmHg and DBP 90 99 mmHg)) were randomized to receive telmisartan 20 mg or telmisartan 20 mg plus resveratrol 1 gram daily for 12 months. In Diabetes study, change in plasma blood glucose (fasting and postprandial); glycosylated hemoglobin (HbA1c); and lipid profile (total cholesterol [TC], Triglycerides [TG], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]) from baseline was assessed. In dyslipidemia study, change in lipid profile (total cholesterol [TC], Triglycerides [TG], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]) from baseline was assessed. In hypertension study, change in systolic blood pressure and diastolic blood pressure from baseline was assessed. Efficacy variable was measured at every 3 months for 12 months for Diabetes, dyslipidaemia and hypertension study. Treatment-emergent adverse events (TEAEs) were assessed at every 3 months for 12 months for Diabetes, dyslipidaemia and hypertension study. newline newline
Pagination: All Pages
URI: http://hdl.handle.net/10603/234494
Appears in Departments:Faculty of Pharmacy

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02_certificate.pdf664.57 kBAdobe PDFView/Open
03_preliminary.pdf305.56 kBAdobe PDFView/Open
04_chapter 1.pdf215.31 kBAdobe PDFView/Open
05_chapter 2.pdf209.97 kBAdobe PDFView/Open
06_chapter 3.pdf311.65 kBAdobe PDFView/Open
07_chapter 4.pdf330.05 kBAdobe PDFView/Open
08_chapter 5.pdf305.56 kBAdobe PDFView/Open
09_chapter 6.pdf224.17 kBAdobe PDFView/Open
10_chapter 7.pdf196.44 kBAdobe PDFView/Open
11_chapter 8.pdf209.67 kBAdobe PDFView/Open
12_references.pdf247.58 kBAdobe PDFView/Open
13_appendices.pdf14.94 MBAdobe PDFView/Open


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