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临床试验/CTRI/2024/08/072274
CTRI/2024/08/072274尚未招募不适用

Efficacy of Risk Mitigation Strategies on Physiological, Bio-chemical and Behavioral Risk factors of Cardiovascular Diseases among Adults.

Sasikala Palayan2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年8月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
2
主要终点
Level of risk cardiovascular diseases will be reduced after 24 months of intervention

研究概览

简要总结

This study is a non randomized control trail multicentric, comparing the efficacy of Risk Mitigation Strategies such as Nurse led education on prevention of risk factors of cardiovascular diseases, alternative nasal breathing, aerobic exercise, sunlight exposure and vitamin D3 supplementation 60000IU per week for 6-8 weeks. The study intervention will be divided into experiemental arm 1 with risk mitigation strategies and arm 2 with supplementaion of vitamin D3. The primary outcome of the study will be measured useing biochemical parameters such as lipid profile, FBS and vitamin D3 level and the secondary outcome will be measure using self structured  behavious modification scale and bio physiological parameters such as BMI, Blood pressure and waist circumferences after 6 months.

研究设计

研究类型
Interventional
分配方式
Na

入排标准

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

入选标准

  • 1 Adults between the ages of 21-60 years.
  • 2 Adults who have mild, moderate level of CVD risk 3 Adult who have deficient and insufficient vitamin D3 level 4 Adults who are willing to participate.

排除标准

  • 1 Adults who are pregnant, skin disorders ( Such as skin burns, Psoriasis etc) 2 Adults who are in steroids and thiazide diuretics.
  • 3 Adults who are already with Vitamin D3 supplements.

结局指标

主要结局

Level of risk cardiovascular diseases will be reduced after 24 months of intervention

时间窗: 24 months

次要结局

  • Improvement in behaviour towards prevention of risk on cardiovascular diseases(6 months)
  • Pysiological risk factors towards cardiovascular diseases will be reduced after the intervention(6 months)

研究者

发起方
Sasikala Palayan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sasikala Palayan

Sri Ramachandra Faculty of Nursing, SRIHER

研究点 (2)

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