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临床试验/CTRI/2024/07/069776
CTRI/2024/07/069776尚未招募3 期

CONCEPT OF TRUPTI AND EVALUATION OF THE EFFICACY OF TRUPTIGHNA MAHAKASHAYA IN SANTRAPANAJANYA STHOULYA VIS-A-VIS INSULIN RESISTANCE IN OBESITY

Dr Shreekantha D Dodmani1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To evaluate the Efficacy of Truptighna Mahakashaya in Santarpanajanya Sthoulya vis-a-vis Insulin Resistance in Obesity

研究概览

简要总结

India is experiencing a rapid health transition with a rising burden of Non-Communicable Diseases (NCD’s) / Life style related disorders (LRD’s) surpassing the burden of communicable or Infectious diseases  Nearly 5.8 million  people (WHO report, 2015) die from NCDS (heart and lung diseases  stroke cancer and diabetes) every year & 1 in 4 Indians has a risk of dying from an NCD before they reach the age of 70 year According to the WHO obesity is a major risk factor for non-communicable diseases such as heart disease, stroke  type 2 diabetes certain cancers and osteoarthritis

The worldwide prevalence of obesity is reaching pandemic proportions The WHO had estimated that in 2016 more than 1.9 billion adults worldwide (39%) were overweight, and over 650 million (13%) were obese  India—has one of the fastest growing obesity rates in the world  It is estimated that there are 135 million obese individuals in India It is very significant to note that in the development of other LRD’s associated with obesity insulin resistance is the intermittent phase of the progressive pathology from obesity to DM and so on

Obesity is not new to Indian knowledge system  Medical works of ancient India like the Bhruhatrayi’s and Laghutrayi’s have documented the diseases of lifestyle origin which are mainly categorized into Santarpanotta vikaras Obesity (sthoulya) is one of the primary symptom as well as a disease of sedentary lifestyle and wrong/ over eating habits (santarpana or atisantarpana)   The causes pathophysiology symptomatology lifestyle modification recommendations  treatments for santarpanotta vikara’s are abundantly found in various chapters and sections of most of the classical Ayurveda works  This area in Ayurveda possesses a great strength and seems to be very much applicable in current health challenge with the rapid explosion of the incidences of LRD’s

‘Trupti’ technically “bhakshanaadina akamksha nivrutti” which means the cessation of the desire for consuming food  it is satiety obtained after having enough quantity of eatables or drinkables  It is the sign of indication to stop consuming the food further  If a person indulge in the consumption of food ignoring the sign of satiety leads to over eating if this practice continued for longer time  habitually  may lead to digestive disturbance which further leads to metabolic derangement and may cause the diseases like “Sthoulya,Prameha”etc

Insulin resistance in obesity is a major concern among middle aged adults in India  It is a state of intermediate metabolic disturbance, which may further lead to Diabetes mellitus. In this condition the body secrets the insulin but tissues are unable to use it due to the loss of sensation of the cells to the molecules of the insulin  As a result of this it causes increase of insulin and glucose in the plasma of blood

The current study intends to understand the concept of Trutpi w s r to the disease Sthoulya and breaking the progressive pathology of obesity leading to many metabolic impairment including hyperglycemia through the administration of Truptighna Mahakashaya in insulin resistance in obesity

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Men Waist Circumference 85cm Waist Hip Ratio(WHR) 0.90 Women Waist Circumference80cm Waist Hip Ratio 0.80 BMI (Kg/m2) 25.1 -35 Fasting blood glucose 100-120 mg/dl Fasting insulin serum 25-40 µU/mL.

排除标准

  • Patients of insulin dependent Diabetes mellitus Pregnant and Lactating women Patients with any other systemic ailments which interferes with the study.

结局指标

主要结局

To evaluate the Efficacy of Truptighna Mahakashaya in Santarpanajanya Sthoulya vis-a-vis Insulin Resistance in Obesity

时间窗: To evaluate the Efficacy of Truptighna Mahakashaya in Santarpanajanya Sthoulya vis-a-vis Insulin Resistance in Obesity which is to be Assessed on baseline and after intervention 7th week with Fasting Blood Glucose and Fasting Insulin Serum

Efficacy of Truptighna Mahakashaya will Evaluate Through Fasting Insulin Serum Test and Fasting Blood Glucose

时间窗: To evaluate the Efficacy of Truptighna Mahakashaya in Santarpanajanya Sthoulya vis-a-vis Insulin Resistance in Obesity which is to be Assessed on baseline and after intervention 7th week with Fasting Blood Glucose and Fasting Insulin Serum

次要结局

  • To evaluate the Efficacy of Truptighna Mahakashaya Insulin Resistance in Obesity(To evaluate the Efficacy of Truptighna Mahakashaya in Insulin Resistance in Obesity)

研究者

发起方
Dr Shreekantha D Dodmani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shreekantha D Dodmani

Government Ayurveda Medical College and Hospital, mysore

研究点 (1)

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