Clinical assessment of treatment efficacy of herbal formulation in reducing hypertension and tocompare with standard medication.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- LOWERING OF BLOOD PRESSURE
研究概览
简要总结
Based on world health organization (WHO) data, worldwide burden of hypertension is substantial, with an estimated 1 billion individuals affected worldwide and 7.1 million deaths per year attributable to hypertension(Forouzanfar et al., 2017). Although several antihypertensive medications are already available and being widely in use but associated side effects like dizziness, headache, dry cough and sexual dysfunction (Bazzano et al., 2008) persuade development of novel and alternative treatments.
The study will be undertaken to assess the efficacy of herbal medication in control of hypertension on mild and moderate clinical patients. The efficacy of herbal medicine will be compared with control drug involving 60 patients each for trial medicine and for control medicine. Thus a total of 120 patients will be part of study. The assessment will be executed by recording of Blood pressure and compare the baseline data with data generated at the end of treatment. The treatment duration of medication will be for a period of 90 days [3 months].
Involvement of allopathic medical practitioner has been included as Co-PI for the research program for selection and usage of standard allopathic drug [Telmisartan] as control. During the course of treatment, Body Mass Index (BMI) will be taken into consideration which is known to have strong linear relationship with hypertension (Landi el at., 2018). Additionally, specific investigations including HbA1C, Renal function test, Lipid Profile, Blood sugar random, and ECG baseline will be conducted.
The primary end point referred in the study include relief from symptoms while the secondary end point involve reduction/control of Systolic and Diastolic Blood Pressure. The clinical assessment will be conducted every 7 days for the first month and subsequently for every two weeks during the treatment phase. The gradation of symptoms will be evaluated based on parameters like Shiroruka (Headache), Hrudravtava (Palpitation), Klama (Fatigability), Bhrama (Dizziness), Aruchi (Anorexia), Vibhanda (Constipation). These clinically subjective parameters will be correlated with objective parameters by recording Systolic and Diastolic blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age group 18-70 years , Either Sex •Essential hypertension : Mild (Systolic BP- 140 to 159mm Hg and /or Diastolic BP- 90 to 99 mmHg) and Moderate (Systolic 160- 179mm of Hg / or Diastolic BP- 100-109).
排除标准
- •1.History of coronary artery disease, myocardial infarction, stroke, transient ischemic attack, any revascularization procedure, congestive heart failure, or hemodynamically significant carotid or peripheral arterial disease 2.Pregnant / Breast feeding women. 3.Women having hormonal contraception or having no effective birth control measure. 4.Diabetes mellitus type I and II 5.As per the opinion of investigator ,any other Surgical /medical illness not mentioned in the protocol.
- •which may place patients at high risk due to their participation in the study OR may lead to their noncompliance to the protocol. 6.Use of other concomitant medications – adrenergic drugs or steroids that may affect blood pressure. 7.Hypersensitivity to any of the test drug
- •Patients with kidney or liver disease.
结局指标
主要结局
LOWERING OF BLOOD PRESSURE
时间窗: • Follow up: Every 7th day for upto 1 month and | every 15th day after one month the patients will | be observed for subjective and objective | parameters will be recorded.
次要结局
- Blood pressure in normal limits is sustained(• Follow up: Every 7th day for upto 1 month and)