CTRI

Dyslipidemia is one of the major escalating public health challenges worldwide, arising as a result of combination of some genetic factors and more importantly certain environmental factors like sedentary life style, increased urbanization, nutritional advancement accompanying economic development, substance abuse and other associated medical conditions. Though in Ayurvedic Brahatrayi, no explicit terminology has been given for Medoroga, Acharya Charaka has described the eight varieties of impediments which are designated as Ashta Nindita Purusha. Atisthaulya (obese) constitutes one of them. Medoroga is described as a separate entity in Madhav Nidaana, Yogratnakara and Bhaishajya Ratnavali . In these literatures, Nidana, Samprapti, Lakhana, with detailed Chikitsa of Medoroga is being mentioned. So, from the perspective of literature available in Samhita, Medoroga shares resemblance with Dyslipidemia. Dyslipidemia is defined as deranged level of lipids in blood due to disorders of lipoprotein metabolism. Clinically, it is characterized by elevated plasma levels of cholesterol, triglycerides or both, accompanied by low level of High Density Lipoprotein Cholesterol (HDL-C).

The prevalence of Dyslipidemia varies around the world depending on the age and ethnicity of population studied. In general, its prevalence increases with age. Though it affects both the genders but studies have shown that males are more predisposed than females. Dyslipidemia is a well-established modifiable risk factor for development of Cardiovascular diseases, Stroke, Type 2 Diabetes, Atherosclerosis etc. According to WHO survey of 2002, the attributable risk of Dyslipidemia in global stroke events and global heart disease is almost 80% and 56% respectively. Since Cardiovascular diseases are one of the leading causes of deaths globally and a strong association is being present between Dyslipidemia and CVDs, timely diagnosis and aggressive management of Dyslipidemia is critical to lower the incidence of mortality caused by CVDs and cerebral strokes.

OBJECTIVES OF THE RESEARCH PROJECT

A. Primary Objectives

1. Improvement in the signs and symptoms of Medoroga.

2. Change in level of hematological parameters of Dyslipidemia (Total Serum Cholesterol, Serum Triglycerides, Serum Low Density Lipoprotein Cholesterol and Serum High Density Lipoprotein Cholesterol)

B. Secondary Objectives

1. Comparison of the therapeutic efficacy of Amritadi Guggulu and Vyoshadi Guggulu after virechana in the management of Medoroga (Dyslipidemia).

2. Changes in â€“ Body Mass Index (BMI), Skin Fold Thickness (Triceps and Abdomen) ,Waist Circumference, Waist Hip Ratio

3. Improvement in the Quality Of Life.

METHODOLOGY

A. Study Design (Pre- Post and also comparative)

The study is proposed to be an Open Randomized Double Arm Clinical Trial. The patients fulfilling Diagnostic Criteria of Medoroga (Dyslipidemia) will be taken in two groups. The subject attending the OPD of AIIA will be screened and enrolled in the study following the ethics of the Institute and the selection criteria.

B. Study Type â€“ Interventional

C. Masking â€“ Open Label

D. Interventional Model â€“ Parallel Assignment

E. Timing- Prospective

F. Method of sample selection â€“ Randomized allocation (on the basis of Random Number Table)

G. Sample size â€“ A minimum of 80 patients of Medoroga (Dyslipidemia), fulfilling the diagnostic criteria will be selected for the proposed clinical trial, 40 in each group.

H. Selection of Cases - O.P.D. /I.P.D. wing of Department of Kayachikitsa, All India Institute of Ayurveda on the basis of Diagnostic Criteria of Medoroga (Dyslipidemia)