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临床试验/CTRI/2025/01/078995
CTRI/2025/01/078995尚未招募不适用

An observational study To find relation between Prameha Hetu and Prediabetic condition with special reference to HbA1C

Not Applicable1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To study the relation between causes of diabetes and Prediabetic condition with

研究概览

简要总结

1.Title

An observational study to find relation between Prameha Hetu and Prediabetic condition with special reference to HbA1C.

2.Objectives

Primary Objective

To study the relation between Prameha Hetu and Prediabetic condition with special reference to HbA1C.

  1. Methodology

I. APPROPRIATE STUDY DESIGN – It is an Observational study.

II.STUDY SETTING – The proposed study will be done in three levels.

LEVEL 1 (CONCEPTUAL) – Ayurvedic literature regarding Hetu of Prameha vyadhi, Prediabetic Condition and HbA1C will be studied.

LEVEL 2 (OBSERVATIONAL) – Relation between Prameha Hetu and Prediabetic condition with special reference to HbA1C will be observed.

LEVEL 3 (ANALYSIS) – Analysis of generated data will be performed for Qualitative and Quantitative data for result.

1)STUDY PLACE – OPD & IPD of Institutional Hospitals and nearby Hospitals of PCMC area.

2)STUDY DURATION – 18 Months.

3)I.STUDY POPULATION – Persons having Prediabetic condition Should be taken & Prameha Hetu will be observed.

4).SAMPLE SIZE – 4(pq)/e2 P=Prevalence rate=10.3%=0.10 [9] q=(1-p)=(1-0.10)=0.9 Error=0.08

Sample size=4(pq)/e2 =4(0.10*0.9/0.08*0.08 =4(0.09)/0.0064 =56.25 So will take 60 persons.

  1. APPROPRIATE SAMPLING TECHNIQUE – Purposive sampling technique will be taken.

6)METHOD OF SELECTION OF STUDY SUBJECT .

A. INCLUSION CRITERIA –

  1. Age group between 30 to 60 years.

  2. Person’s having HbA1C 5.7%-6.4% will be selected .

3..Patient will be selected Irrespective of their Gender, religion, socio-economical class and marital status.

B.EXCLUSION CRITERIA –

1.Diabetes Mellitus and its complications, Patients having Liver diseases, kidney diseases, malignancies and major illnessess will be excluded.

2.Patient’s on sterodial medications, Alcoholic person’s will be excluded

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Age group between 30 to 60 years.
  • Person’s having HbA1C 5.7%-6.4% will be selected 3.Patient will be selected Irrespective of their Gender, religion, socio-economical class and marital status.

排除标准

  • 1.Diabetes Mellitus and its complications, Patients having Liver diseases, kidney diseases, malignancies and major illnessess will be excluded.
  • 2.Patient’s on sterodial medications, Alcoholic person’s will be excluded.

结局指标

主要结局

To study the relation between causes of diabetes and Prediabetic condition with

时间窗: 10 months

special reference to HbA1C.

时间窗: 10 months

次要结局

  • NA(NA)

研究者

发起方
Not Applicable
申办方类型
Other [Not Applicable]
责任方
Principal Investigator
主要研究者

Vd Kavita Balasaheb Argade

Department of Rognidan Avum Vikriti vigyana

研究点 (1)

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