跳至主要内容
临床试验/CTRI/2024/12/078230
CTRI/2024/12/078230尚未招募不适用

An observational study of Ashtadosha lakshana of Medoroga in sthool pramehi with special reference to HbA1C level

Not Applicable1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1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
70
试验地点
1
主要终点
To study the realationship of Eight Cardinal Symptoms of Obesity Related disorder in Obese diabetic patients with Special Reference to HbA1C Levels

研究概览

简要总结

  1. Title An observational study of Ashtadosha lakshana of Medoroga in sthool pramehi with special reference to HbA1C level.

  2. Objectives

Primary Objective -To study the relation between Ashtadosha lakshana of Medoroga and HbA1C level in sthool pramehi.

Secondary Objective- To study the relation between Ashtadosha lakshana of Medoroga and BMI in sthool Pramehi.

  1. Methodology

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

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

L EVEL 1 (CONCEPTUAL) – Ayurvedic literature regarding Ashtadosha lakshana of Medoroga, Sthool Pramehi, modern concept of Type 2 Diabetes mellitus, and HbA1C will be studied.

LEVEL 2 (OBSERVATIONAL) –Observation of Ashtadosha lakshanas of Medoroga in sthool pramehi with special reference to HbA1C will be done.

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

STUDY PLACE –Institutional Hospital

STUDY DURATION –18 Months.

III.STUDY POPULATION – 6 Known cases of Diabetes mellitus having BMI ≥25kg/m2

IV.SAMPLE SIZE –4(pq)/e2 p-prevalence rate i.e.0.11[16] q=1-p=0.89 e=allowable error=0.08 sample size=4(pq)/e2 =4*0.11*0.89/ (0.08)2 =61.187

For convenience purpose 70 patients will be taken

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

VI.METHOD OF SELECTION OF STUDY SUBJECT –

A. INCLUSION CRITERIA –

  1. Age group between 30 to 60 years
  2. known cases of Diabetes Mellitus having BMI≥25kg/m2
  3. Irrespective of gender, caste, socio-economical class and marital status.

B. EXCLUSION CRITERIA – 1.Patients suffering from Tuberculosis, Rheumatoid arthritis and Thyroid. 2. Patient’s on steroidal medications. 3. Known cases of Systemic lupus erythematous, Malignancy etc.

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)(—)
性别
All

入选标准

  • known cases of Diabetes Mellitus having BMI≥25kg/m2.

排除标准

  • 1.Patients suffering from Tuberculosis, Rheumatoid arthritis and Thyroid.
  • Patient’s on steroidal medications.
  • Known cases of Systemic lupus erythematous, Malignancy etc.

结局指标

主要结局

To study the realationship of Eight Cardinal Symptoms of Obesity Related disorder in Obese diabetic patients with Special Reference to HbA1C Levels

时间窗: 12 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 Rajashri Ganpat Mane

Department of Rognidan Avum Vikriti vigyana

研究点 (1)

Loading locations...

相似试验