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临床试验/CTRI/2020/11/029219
CTRI/2020/11/029219尚未招募2 期

EFFICACY OF AAROGYAVARDHINI VATI WITH AARAGWADHA PHALA MAJJA KSHEERPAKA [CASSIA FISTULA LINN] IN THE MANAGEMENT OF PRIMARY HYPERTENSION- A RANDOMIZED COMPARATIVE OPEN CLINICAL TRIAL

Dean Faculty of Ayurved Parul University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年11月23日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
63
试验地点
1
主要终点
Systolic blood pressure

研究概览

简要总结

Hypertension is called a ‘silent killer’. Most people with hypertension are unaware of the problem because it may have no warning signs or symptoms. It is chronic non communicable disease in which the pressure exerted by the blood on the  wall of the artery is elevated. It is classified as Primary Hypertension & Secondary hypertension. 

In Ayurveda there is no description of such a single disease which can resemble with hypertension.

The global burden of HTN is anticipated to increase by 60% to affect approximately 29.2 % of adult population that accounts to 1.56 billion adults worldwide by 2025. The current therapeutic strategy involves use of various pharmacological agents like β blockers, ACE inhibitors, calcium channel blockers, α blockers and diuretics. However, use of these drugs is affected because various hindrances like side-effects and cost-effectiveness. These drugs help in altering the physiopathology and there are not going cure the disease.

This condition if remain untreated it further leads to cardiovascular disease, Renal disease, Vascular disease and advance hypertensive retinopathy etc. Hence, there is a strong need to search safe and cost-effective options for the management of hypertension considering metabolic disturbance.

So Aarogyavardhini vati with Aaragwadha phala majja Ksheerpaka will be used in management of primary hypertension to see effectiveness of drug.

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

  • Age:- Patients of either sex between 20 and 65 years.
  • (both years inclusive) Diagnosed hypertension patients.
  • K/c/o hypertension with or without antihypertensive drugs.(With or without symptoms).
  • Patients with Stage 1 hypertension SBP(140–159)/DBP(90-99) mm of Hg & Stage 2 hypertension SBP(160–179)/DBP(100–109) mm of Hg.

排除标准

  • Acute hemorrhagic condition, Acute septic shock K/c/o hypertension history more than 12 years.
  • Hypertensive emergency i.e. blood pressure more than 180/120mm of Hg. Secondary hypertension.
  • Pregnancy-induced hypertension.
  • Pregnant and lactating women.

结局指标

主要结局

Systolic blood pressure

时间窗: effect on Systolic blood pressure and Diastolic blood pressure and Mean Arterial pressure at baseline and at the end of 10 days till 1 month

Mean Arterial pressure

时间窗: effect on Systolic blood pressure and Diastolic blood pressure and Mean Arterial pressure at baseline and at the end of 10 days till 1 month

Diastolic blood pressure

时间窗: effect on Systolic blood pressure and Diastolic blood pressure and Mean Arterial pressure at baseline and at the end of 10 days till 1 month

次要结局

  • Lipid profile(effect on Lipid profile at baseline and at the end of 10 days till 1 month)

研究者

发起方
Dean Faculty of Ayurved Parul University
申办方类型
Private medical college

研究点 (1)

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