Randomized controlled trial of Anshumati Ksheer Paka in hypertension induced left ventricular hypertrophy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Changes in Left Ventricular Mass Index from baseline
研究概览
简要总结
Prevalence of LVH increases with severity of hypertensive disease. Approximately one third to half of hypertensive patients have LVH. The prevalence of LVH ranges from 5% in patients undergoing angiography to as much as 44% in patients with hypertension.
Anti hypertensive drugs such as angiotensin-converting enzyme inhibitors, ARB’s , β-blockers etc. are effective in attenuating the LVH and heart failure. However, in recent years, researchers have shown considerable interest in treating diseases with medicinal plants because of their low toxicity and potential pharmacological properties. Medicinal plants have been used in the Indian system of medicine to treat various diseases, including infectious and non-infectious ones.
Desmodiumgangeticum (Fabaceae family) is a small medicinal shrub abundantly found in tropical countries such as India, China, Africa, and Australia (Kurian et al., 2010). The root portion of this plant is used as the main ingredient in famous ayurvedic preparations such as “Dashmoola. This medicinal herb is used to treat various ailments such as digestive, inflammatory, and cardiovascular disorders. Moreover, invitro studies have shown that DG root extracts possess strong antioxidant, anti-hypertrophic, and anti-inflammatory activities (Sankar et al., 2013). Hence, the present study was designed to investigate the efficacy and safety of “AnshumatiKsheerPaka†in Hypertension induced Left Ventricular hypertrophy, as add on therapy to Standard care.
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
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •2.Participants diagnosed with LVH having left ventricular mass index more than 115 g/m2 in men, and more than 95 g/m2 in women, as evidenced by echocardiography.
- •3.Participants having mild to moderate Hypertension (grade 1 and 2) 4.Participant willing and able to give informed consent.
排除标准
- •1.Left Ventricular Ejection Fraction less than 45% on screening echocardiography.
- •2.History of myocardial infarction or stroke within 6 months 3.History of Heart failure, ischemic heart disease, valvular heart disease, arrhythmias, peripheral vascular disease, history of any type of cardiac surgery.
- •4.Renal dysfunction, chronic kidney disease (GFR less than 60 ml/min), Significant chronic renal impairment (Serum creatinine more than 2.0 mg/dL).
- •5.Severe hypertension (Systolic BP more than or equal to 180 mm Hg or Diastolic BP more than or equal to 110 mm Hg).
- •6.Diabetic patients with HbA1c more than 7%.
- •7.Diagnosed Patients of Dyslipidemia having values of total Cholesterol (more than 240 mg/dl), Low Density Lipoprotein (LDL more than 160 mg/dl), Triglycerides (more than 200 mg/dl) and High Density Lipoprotein (HDL less than 40 mg/dl) 8.Known cases of lactose intolerance.
- •9.Participants who have participated in any other clinical trial within the previous 30 days.
- •10.Pregnant/lactating females 11.Participants with a history of substance abuse or alcohol abuse and smokers 12.Any other condition which the P.I. thinks may jeopardize the study.
结局指标
主要结局
Changes in Left Ventricular Mass Index from baseline
时间窗: Baseline, 3 months, 6 months
次要结局
- 1.Number of participants with reduction of left ventricular hypertrophy(2.Changes in Left Ventricular Ejection Fraction)