Randomized controlled clinical trial to evaluate an add on effect of Tagar Vati in the management of Essential Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1.Blood pressure monitoring
研究概览
简要总结
Hypertension is one of largest non-communicable disease in India.[8] It causes more death worldwide, due to cardiovascular diseases. There are lots of medicinal availability for blood pressure treatment but it is limited due to phenomena of drug inertia. The national health and nutritional examination survey reported that around 16 million hypertensive patients are on medication but still they do not have controlled blood pressure.[9]
People who are suffering from hypertension started antihypertensive generally for lifetime. This leads into some toxicity or side effects of the medicines. Side effects of beta blocker may include hypotension, bradycardia, dizziness, cold fingers, insomnia, fatigue, impotence etc. Severe side effects may include bronchoconstriction, arrhythmias, hypoglycemia etc.
Modern Medicines are usually single targeted and long term use of any single group leads to treatment failure in long term. Addition of multiple antihypertensive is usual observation in routine clinical practice. In modern medicine anti-hypertensive drugs lower the high blood pressure but do not wholesomely eradicate the risk of cardiac-cerebrovascular-renal-ophthalmic involvement, But Ayurveda therapy can minimize the risk factor in a better way. Hence for the hypertension cases, we have chosen Tagar Vati. Contents in the Tagar Vati i.e. Tagar is readily available, and this medicine is available throughout in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having Stage I hypertension, isolated systolic and isolated diastolic hypertension.
- •Patients who is known case of Hypertension but not suffering from more than 10 years.
- •Also known case of hypertension with or without antihypertensive.
- •Shirashool, Bhrama, Klama, Hridspandana, Anidra, Swedadhikya ,Shwaskashtata patient having these symptoms of Hypertension will be included in the clinical study .
- •Patients in between 20 to 60 years of age.
- •Patients having serum creatinine level less than 1.5 mg/dl.
- •Patients with raised blood pressure with Beta blocker.
排除标准
- •Patients having Stage II, stage III and above known case of hypertension will be excluded.
- •Pregnant women and lactating mothers.
- •Patient suffering from any other serious systemic illness like cerebrovascular diseases, Acute Haemorrhagic conditions, Acute septic shock etc.
结局指标
主要结局
1.Blood pressure monitoring
时间窗: At base line, 15 days and 30 days
2.Serum creatinine
时间窗: At base line, 15 days and 30 days
3.Lipid Profile
时间窗: At base line, 15 days and 30 days
4. ECG
时间窗: At base line, 15 days and 30 days
次要结局
未报告次要终点
研究者
Yogesh Tukaram Kotangale
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune