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临床试验/CTRI/2009/091/001012
CTRI/2009/091/001012未知不适用

Effects of the walnut consumption in the young male patients of Essential Hypertension on sleep, stress,blood pressure and various parameters of Anthropometry.

Dr. Gullapalli H.S.,SVP II/11, Shreepuram,Kamineni Institute of Medical Sciences Campus,Narketpally-NalgondaAndhra PradeshIndia-5082541 个研究点 分布在 1 个国家目标入组 0 人开始时间: 待定
适应症

试验速览

阶段
不适用
发起方
试验地点
1
主要终点
A] Stress: By using perceived stress scale B] Sleep: By using Epworth Sleepiness Scale(and Petersburg Sleep Quality Index. C] Blood Pressure: .C] Blood Pressure:Systolic Blood pressureDiastolic Blood Pressure D] Anthropometry: Parameters-1] Body Mass Index2] Waist Circumference3] Hip circumference4] Waist-to-hip ratio

研究概览

简要总结

This is a follow-up intervention study. In which the base line values are recorded and the dietary intervention done using 20 grams of walnut everyday in their die for 5 weeks . They are not instructed for any diet change except the inclusion of walnut in the daily diet. They are asked to consume walnut in the two divided doses in the form of snacks or salads 10 gram in each session before or after meals. The patients are asked to go through the questionnaire like Epworth Sleepiness scale questionnaire, Petersburg Sleep Quality Index questionnaire for sleep quality and Perceived stress scale questionnaire for stress and answer them. With the help of the methodology available in these format the scoring is done for sleep and stress before start of the study and at the end of the study. The baseline readings for the the blood pressure is recorded in accordance with the European Society of Hypertension guideline, 2007 for blood pressure measurement in the sitting position with the help of Mercury Sphygmomanometer before the start and end of the study. Various anthropometric measurements are done like height, weight, waist, hip circumference. The body mass index and Waist-to-hip ratio is calculated with the help of the standard available formula. These measurements are taken at the start and on the end of the study period.

研究设计

分配方式
Not Applicable
盲法
Open Label

入排标准

入选标准

  • •1] Age: 34 to 42 Years2] Sex: Male3] Essential Hypertension Stage I according the guidelines issued by the European Society of Hypertension4] Body Mass index > 27 Kg/ m2.

排除标准

  • •Food allergyAllergy to the consumption of nutsHeavy SmokersRecent hypolipdaemic drug consumption1]Abnormal obesity2]Familial history of lipid disorders3]Complicated Hypertension with end organ damage like Left 4]ventricular hypertrophy, chronic renal failure, stroke, cerebrovascular accidents etc.

结局指标

主要结局

A] Stress: By using perceived stress scale B] Sleep: By using Epworth Sleepiness Scale(and Petersburg Sleep Quality Index. C] Blood Pressure: .C] Blood Pressure:Systolic Blood pressureDiastolic Blood Pressure D] Anthropometry: Parameters-1] Body Mass Index2] Waist Circumference3] Hip circumference4] Waist-to-hip ratio

时间窗: In 5 weeks.

次要结局

未报告次要终点

研究者

发起方
Dr. Gullapalli H.S.,SVP II/11, Shreepuram,Kamineni Institute of Medical Sciences Campus,Narketpally-NalgondaAndhra PradeshIndia-508254

研究点 (1)

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