A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF VAMANA, VIRECHANA AND BASTI ON SERUM ADIPONECTIN LEVEL IN THE MANAGEMENT OF T2DM WITH OBESITY (STHULA PRAMEHI) AN EXPLORATORY STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- an improvement in serum adiponectin levels following intervention with vamana, virechana and basti.
研究概览
简要总结
INTRODUCTION
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Hyperglycaemia, or raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems, especially the nerves and blood vessels. impaired insulin secretion, and increased glucose production. Diabesity, the term coined to show the strong interlink between obesity and diabetes, is the direct co nsequence of the obesity pandemic, and poses significant challenges in the management of the disease. The global prevalence of obesity is increasing rapidly with an exponential rise in incidence of type 2 diabetes mellitus in recent years. The worst metabolic consequence of obesity is type 2 diabetes mellitus , which substantially increases cardiovascular disease-related morbidity and mortality. Other obesity associated comorbidities such as dyslipidemia, hypertension, metabolic-associated fatty liver disease, obstructive sleep apnoea , heart failure, ischaemic heart disease, cancers and osteoarthritis further increase the morbidity, mortality, and health-related quality of life, especially when these patients additionally have T2DM
NEED OF STUDY - The rising prevalence of obesity-induced Type 2 Diabetes Mellitus (T2DM) poses a major global health burden, with increasing incidence in both urban and rural populations. Among various biomarkers, serum adiponectin has gained attention for its anti-inflammatory, insulin- sensitizing, and cardio-protective roles. While conventional treatments focus on glycemic control and metabolic risk reduction, they do not address the underlying pathophysiology from a holistic perspective. Ayurveda, with its comprehensive approach, offers Shodhana therapies (bio-purificatory procedures) like Vamana, Virechana, and Basti, which aim to eliminate the root cause (Dosha-Dushya imbalance), particularly addressing Kapha-Meda Dushti — the core pathology in obesity and diabetes (Sthoulya-Prameha).
OBJECTIVES
PRIMARY****OBJECTIVE—
To compare the effect of Vamana, Virechana, and Basti on serum adiponectin levels in patients of t2dm with obesity (sthula pramehi)
SECONDARY OBJECTIVES-
1. To assess changes in clinical parameters such as BMI, waist circumference, hip waist ratio.
2. To assess changes in biochemical parameters like fasting blood sugar , postprandial blood sugar , HbA1c, and lipid profile.
- To compare the overall effect of these Panchakarma procedures in improving quality of life and disease outcome.
4. To assess changes in signs and symptoms based on ayurvedic and modern parameter
METHODOLOGY:
This study is a prospective, triple arm interventional clinical trial with an open-label design, conducted over a period of 2.5 years on diagnosed cases of psoriasis, in both outpatient and inpatient departments (OPD & IPD) of the All India Institute of Ayurveda (AIIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient having classical signs and symptoms of Diabesity or Sthula Pramehi according to Ayurveda as well as modern science.
- •Patients diagnosed with Diabetes or Pre-Diabetes.
- •Body Mass Index more than twenty-three and less than forty kilograms per meter square.
- •Fasting Blood Sugar more than one hundred ten milligrams per decilitre and up to two hundred milligrams per decilitre.
- •Postprandial Blood Sugar more than one hundred forty milligrams per decilitre and up to three hundred milligrams per decilitre.
- •HbA1c between five point seven and seven point zero percent.
- •Age between thirty to sixty years.
- •Any gender.
- •All socio-economic statuses included.
- •Patient must be fit for Ayurvedic procedures including Vamana Virechana and Basti.
排除标准
- •Age less than 30 years and more than 60 years.
- •Patients of Prameha having Body Mass Index less than 23 kg per square meter and more than 40 kg per square meter.
- •Patients with chronicity of disease more than five years.
- •Patients diagnosed with Type 1 Diabetes Mellitus.
- •Patients having complications of diabetes such as nephropathy diabetic ulcer etc.
- •Pregnant and lactating women.
- •Patients having high blood pressure more than 160 by 100 millimeters of mercury.
结局指标
主要结局
an improvement in serum adiponectin levels following intervention with vamana, virechana and basti.
时间窗: 0th day,50th day
次要结局
- objective parameter- An improvement in BMI, waist circumference, hip-waist ratio, FBS, PPBS, HbA1c, lipid profilesubjective parameter-An improvement in signs & symptoms based on ayurvedic & modern parameters . Improvement in quality of lifeResults will guide future controlled trials & integrative management strategies.(0th day,20th day,50th day,100th day)
研究者
Dr Nicky Yadav
All India Institute of Ayurveda
