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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in blood sugar level (fasting and fed), lipid profile and SBP and DBP from baseline to end of study visit (12 month)
研究概览
简要总结
As we all know diabetes, dyslipidemia and hypertension is common cause of morbidity and mortality in India. To manage aforesaid disease effectively, often combination therapy and adjusting dose of gold standard therapy from low to high is required to prevent mortality. This may results in long term safely issues and add financial burden to patients and their family. To prevent side effects and financial burden due to combination therapy and high dose of gold standard therapy, there is need of an effective adjuvant therapy which is free from side effects, cost effective and enhances the efficacy of current gold standard therapy without the need of switching to aggressive therapy. Also there is a need of adjuvant therapy which keeps us healthy and useful as prophylaxis for the patients with risk factor of cardiovascular disease. The objective of this study: 1) To evaluate the efficacy and safety of resveratrol as an adjuvant therapy in patients with Diabetes, Dyslipidemia and Hypertension. 2) To determine the effect of resveratrol in prevention of dyslipidemia in patients with type 2 diabetes mellitus (T2DM).
Findings: In Diabetes study, a total of 60 T2DM patients with borderline dyslipidemia were analyzed (glimepiride [n=30] and glimepiride plus resveratrol [n=30]). Resveratrol as an adjuvant with glimepiride significantly reduced plasma blood glucose concentration as compared to glimepiride monotherapy during fasting and postprandial conditions (p<0.001). Mean levels of HbA1c were significantly lower in glimepiride plus resveratrol group than glimepiride (p<0.001). Significantly lower mean serum levels of TC, TG and LDL were observed in resveratrol plus glimepiride group than glimepiride (p<0.001). Mean serum levels of HDL was significantly higher in resveratrol plus glimepiride group than glimepiride (p<0.001). Both the study drugs have similar safety profile. In dyslipidemia study, a total of 60 dyslipidemia patients with borderline hypertension were subjected to statistical analysis (atorvastatin [n=30] and atorvastatin plus resveratrol [n=30]). Significantly greater reduction in lipid levels (TC, TG, LDL and VLDL) were observed in patients treated with atorvastatin plus resveratrol when compared to atorvastatin monotherapy (p<0.001). Mean HDL levels were also significantly higher in resveratrol plus atorvastatin group than atorvastatin monotherapy (p<0.001). Both the study drugs have similar safety profile. In hypertension study, a total of 60 hypertensive patients were analysed (telmisartan [n=30] and telmisartan plus resveratrol [n=30]). Significant greater reduction in blood pressure (systolic and diastolic) was observed in telmisartan plus resveratrol group when compared to telmisartan monotherapy group (p<0.001). Both the study drugs have comparable safety profile and found well tolerable.
Conclusions: In Diabetes study, resveratrol as an adjuvant therapy was found to be well tolerated and effective in T2DM; and also prevents progression of T2DM induced dyslipidemia. In dyslipidemia study, resveratrol plus atorvastatin was found to be superior over atorvastatin monotherapy in improving lipid levels in dyslipidaemia patients.In hypertension study, resveratrol plus telmisartan was found to be superior over telmisartan monotherapy in reducing systolic and diastolic blood pressure in hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetes study: Patients of either gender with known T2DM, aged between 20 and 65 years Patient with borderline blood lipid abnormality and not taking any hypolipidemic agents Patient is on stable monotherapy of Glimeperide 2 mg Patient willing to use Plant based therapy (RESVERATROL) with gold standard therapy in management of their T2DM.
- •Dylipidemia study: Patients with either sex in the age group of 20-65 years suffering from dyslipidemia Patient who are on stable therapy of Atorvastatin 10 mg tablet Patient willing to use Plant based therapy (RESVERATROL) with gold standard therapy (Statin) in management of dyslipidemia.
- •Hypertension study: Patients of either sex, aged 20-65 yrs Patients with Stage I hypertension (SBP 140–159 mmHg and DBP 90–99 mmHg) Patients taking monotherapy of Telmisartan 20 mg Patient willing to use Plant based therapy (RESVERATROL) with gold standard therapy (Telmisartan 20 mg) in management of hypertension.
排除标准
- •Diabetes study: Patients who are willing to use other antioxidant supplementation rather than RESVERATROL Patients with type 1 diabetes, pregnant women and lactating mothers Patients with dyslipidemia and taking lipid lowering therapy including statin Patients with history of severe heart disease, hepatic and renal dysfunction Patients taking/requiring beta – blocker and any drug which produce hyperglycemia or hypoglycemia.
- •Patients with history of allergy with grapes and consume alcohol daily Dylipidemia study: Patients who are willing to use other antioxidant supplementation rather than RESVERATROL Pregnant women and lactating mothers Patients taking/requiring any drug which affect blood lipid level Patients with history of diabetes, severe heart disease, hepatic and renal dysfunction Patients with history of allergy with grapes and consume alcohol daily Hypertension study: Patients who are willing to use other plant based therapy rather than RESVERATROL Patients taking/requiring any drug which affect blood pressure Pregnant women and lactating mothers Patients with history of severe heart disease, hepatic and renal dysfunction Patients with history of allergy with grapes and consume alcohol daily.
结局指标
主要结局
Change in blood sugar level (fasting and fed), lipid profile and SBP and DBP from baseline to end of study visit (12 month)
时间窗: At baseline and 12 month
次要结局
- Change in blood sugar level (fasting and fed), lipid profile, Hemoglobin A1c and systolic and diastolic blood pressure(Baseline, at the end of 3 month, 6 month and 9 month)