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临床试验/CTRI/2025/03/081971
CTRI/2025/03/081971尚未招募2 期

A Randomized Controlled Trial To Evaluate The Effecacy Of Madhumehari Churna And Diet Modification On Serum Blood Glucose Level In Pre-Diabetes Patients

National Institute Of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Changes in blood glucose level

研究概览

简要总结

NEED OF STUDY:

According to the International Diabetes Federation, Pre-diabetes has a prevalence of 16.8% worldwide. In India, its prevalence is 10.3% [4]. Since Pre-diabetes is a condition with a very significant prevalence, and if left unaddressed, can lead to serious conditions like Diabetes Mellitus, Cardiovascular diseases and Stroke, use of Madhumehari Churna or diet modifications for limiting this condition in the pre-pathogenesis stage can be a very beneficial treatment regimen.

Non-communicable diseases pose a great threat to Global Health in the present era, and Pre-diabetes is a precursor to various such non-communicable diseases. Elevated glucose level is an important metabolic risk factor for non-communicable diseases and unhealthy dietary habits is also an important modifiable risk factor in the development of non-communicable diseases. This study addresses elevated glucose level through the use of Madhumehari Churna and unhealthy dietary habits through diet modification.

Moreover, limiting any disease in its pre-pathogenesis stage is an important type of primary prevention, a very effective level of prevention in disease epidemiology. There have been some researches done on effect of Madhumehari Churna in Diabetes but we do not find researches done on its effectiveness in Pre-diabetes condition. Hence, this study can be helpful in finding a way to limit pre-diabetes so that it doesn’t progress into even serious conditions.

AIM:

To assess and compare the efficacy of Madhumehari Churna and Diet Modification in Pre-diabetic patients.

OBJECTIVES:

Primary Objective: To compare the efficacy of Madhumehari Churna and Diet Modification in Pre-Diabetic Patients in reducing fasting blood glucose level.

Secondary Objective:

  1. To assess the impact of both interventions on HbA1c level, Lipid Profile and BMI.
  2. To prepare a diet module for prediabetic persons.

RESEARCH QUESTION:

Does Madhumehari Churna demonstrate any effect in management of Pre-diabetic patients compared to Diet Modification?

HYPOTHESIS:

Null Hypothesis [Ho]: There is no difference in the efficacy of Madhumehari Churna compared to Diet Modification on serum blood glucose level in Pre-diabetic patients.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients between the age group of 18-60 year of either sex.
  • Fasting blood glucose level within range 110-125 mg/dl.
  • HbA1c level within range 5.7-6.4%.

排除标准

  • Those already diagnosed with diabetes.
  • Subjects with serious medical, surgical or oncological conditions.

结局指标

主要结局

Changes in blood glucose level

时间窗: 15 Days

次要结局

  • Changes in HbA1c level, Lipid profile & BMI(0 & 12 weeks)

研究者

发起方
National Institute Of Ayurveda Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Yogesh Kumar Khatarker

National Institute Of Ayurveda Jaipur

研究点 (1)

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