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临床试验/CTRI/2024/04/066385
CTRI/2024/04/066385尚未招募不适用

Adhyashanam and the risk of Metabolic Syndrome among population aged 30-50 years: a case – control study.

Dr Deepty Nair1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年6月5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
210
试验地点
1
主要终点
oTo study the association between dietary patters especially Adhyasanam & Metabolic Syndrome among the population aged 30-50 years.

研究概览

简要总结

•         Based on the Inclusion and Exclusion criteria including clinical and laboratory assessment -Anthropometric Assessment (Height, Weight, BMI, Waist Circumference), General Assessment (Blood Pressure) Laboratory Assessment (Serum Triglycerides, Serum HDL, Fasting Blood Glucose Level) subjects will be recruited to the case group.

•         Based on the Inclusion and Exclusion criteria matched controls will be recruited to the control group from among the healthy family members of the cases.

•         Informed Consent will be collected from both cases and controls.

•         Initial assessment will be done including physical examination and laboratory investigations and data will be recorded.

•         Data collection to assess the practice of Adhyashanam will be done using the validated questionnaire.

•         Data analysis and comparison among the groups will be done and Odd’s ratio will be calculated to find the association between Adhyashanam and Metabolic Syndrome.

•         Risk association will be assessed using chi square test.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Diagnosed patients of Metabolic Syndrome or subjects having any three of following 5 criteria i.e., fasting plasma glucose ≥110 mg/dl, serum triglycerides ≥150 mg/dl, serum HDL cholesterol <40 mg/dl, BP ≥130/85 mmHg, Hypertension, Dyslipidemia, or on medication for DM, HTN or Dyslipidemia; and waist girth >102 cm.
  • 2.Patient of either sex, male and female, in the age group 30-50 years.
  • 3.Healthy family members of either sex, male and female, (not satisfying the diagnostic criteria for Metabolic Syndrome) in the age group 30-50 years will be included as the controls for the study.

排除标准

  • 1.Patients with secondary complications of metabolic syndrome including cardio vascular disease, stroke, cancer and renal diseases.

结局指标

主要结局

oTo study the association between dietary patters especially Adhyasanam & Metabolic Syndrome among the population aged 30-50 years.

时间窗: 18 months (at the end of the study and data analysis)

次要结局

  • oTo study the association between Adhyashanam & Blood Glucose values among the population aged 30-50 years.(oTo study the association between Adhyashanam & Lipid Profile among the population aged 30-50 years.)

研究者

发起方
Dr Deepty Nair
申办方类型
Other [self]

研究点 (1)

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