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临床试验/CTRI/2025/03/081817
CTRI/2025/03/081817尚未招募2/3 期

RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF GOKSHURADI KWATH AND KAKUBHADI CHURNA IN THE MANAGEMENT OF AAVRIT VYAAN W.S.R. TO ESSENTIAL HYPERTENSION

Ayurvedic and Unani Tibbia College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
change in Systolic & Diastolic Blood pressure.

研究概览

简要总结

•Hypertension

  • or elevated blood pressure - is a serious medical condition that significantly increases the risk of heart attack, stroke, kidney failure and blindness. It is also called silent or hidden killer because most of the sufferers (85%) are asymptomatic and as per available  survey reports, in more than 95% cases of hypertension underlying cause is not known.

•Prevalence of hypertension is increasing in many countries as well as in India, Incidence of Hypertension has gone up from 5% in the 1960s to nearly 12% in 1990s, and more than 30% in 2008.

•It is one of the leading causes of premature death worldwide killing nearly 9.4 million people every year globally.

•There is no direct reference of Hypertension in Ayurvedic classics by nomenclature. So on the basis of Sign & Symptoms it can be corelated to Aavaran of Vyaan Vaat.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Subjects willing to participate and able to provide written informed consent.
  • Patient diagnosed as Stage- 1 Essential hypertension would be selected for study on the basis of 8th JNC & WHO criteria.

排除标准

  • Patient diagnosed as secondary hypertension or pre-hypertension or taking any Antihypertensive drug.
  • Subjects with any previous Cardiovascular disease or known cases of MI,unstable angina or CHF.
  • Subject suffering from any hepatic disorder (SGPT and SGOT more than two times the upper limit of normal) or Renal dysfunction, uncontrolled Pulmonary dysfunction (asthmatic and COPD subjects).Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).Pregnant / Lactating women.Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.Subjects who have completed participation in any other clinical trial during the past six (06) months.

结局指标

主要结局

change in Systolic & Diastolic Blood pressure.

时间窗: Baseline & Day 91

次要结局

  • change in assessed symptoms of Essential hypertension.(Day 1,91)

研究者

发起方
Ayurvedic and Unani Tibbia College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aman Raj

Ayurvedic and Unani Tibbia College and Hospital

研究点 (1)

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