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临床试验/CTRI/2024/10/074864
CTRI/2024/10/074864已完成不适用

Grain Free Diet on Hypertensive Individuals - A Pilot Study

Ankitha Rao1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

Hypertension has become a major public health issue worldwide. The main causes include sedentary lifestyle, unhealthy eating habits, smoking, etc. Diet plays a major role in managing hypertension. A grain-free diet eliminates all grains, including wheat, spelt, barley, rye, dried corn, millet, rice, and oats, as well as foods and sometimes even ingredients that are made from them. The purpose of this study is to see the effect of grain free diet on hypertension. The study is single arm study with sample size of 20 participants consisting both males and females of ages 30 years to 60 years. The intervention is for 7 day and parameters will be checked at baseline and at end. Blood pressure both Systolic and Diastolic, Pulse rate, Pulse pressure and mean arterial pressure are the parameters in this study. After collection of data, result will be drawn by using JAMOVI software and p value will be calculated. The primary outcomes will be reduction in all the parameters. Based on the results the discussion and conclusion of the study will be drawn.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Both male and female subjects will be included in the study
  • Age group between 30 to 60 without any serious physical illnesses like tuberculosis, heart diseases would be included in the study.
  • Subjects with hypertension who is on oral anti-hypertensives.

排除标准

  • Subjects with the age group below 30 and above 60 will be excluded from the study.
  • Subjects with complications like chronic kidney diseases and post trauma/ surgery will be excluded from the study.
  • Subjects with cardiovascular diseases.

结局指标

主要结局

Blood Pressure

时间窗: Outcomes will be checked at baseline and after 7 days of intervention

Pulse Rate

时间窗: Outcomes will be checked at baseline and after 7 days of intervention

Pulse Pressure

时间窗: Outcomes will be checked at baseline and after 7 days of intervention

Mean Arterial Pressure

时间窗: Outcomes will be checked at baseline and after 7 days of intervention

次要结局

  • Blood Pressure(Pulse Rate)

研究者

发起方
Ankitha Rao
申办方类型
Other [Self Sponsor]
责任方
Principal Investigator
主要研究者

Ankitha Rao

SDM College of Naturopathy and Yogic Sciences

研究点 (1)

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