Comparing the efficacy of Amritadi Guggulu and Vyoshadi Guggulu after Virechana (Therapeutic Purgation) in patients of Medoroga (Dyslipidemia)

Not yet recruiting

• Conditions: Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,

• Registration Number: CTRI/2022/02/039995
• Lead Sponsor: All India Institute Of Ayurveda

Brief Summary

INTRODUCTION

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 – 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 – Interventional

C. Masking – Open Label

D. Interventional Model – Parallel Assignment

E. Timing- Prospective

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

G. Sample size – 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)

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-13
• Study Start: 2022-02-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patient with Pratyatma Lakshan of Medoroga Patient fulfilling the Diagnostic Criteria of Dyslipidemia Patients of Age group between 21 to 50 years irrespective of gender, caste, creed and body weight Patients fit for Virechana karma Patient willing and able to give written consent in the study.

Exclusion Criteria

• Patients with poorly controlled Diabetes Mellitus (HbA1c >10%) and Hypertension ( BP > 160 / 100 mm Hg) Pregnant / lactating woman Patients with genetic syndromes, severe cardiovascular disease or any other life threatening condition.
• History of hypersensitivity to any of the trial drugs or their ingredients.
• Patients unfit for Virechana karma Patients having systemic illness which will interfere with the course of procedure.
• Patients who are already enrolled in other study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the haematological parameters of Dyslipidemia	Before and After Treatment
Improvement in the Signs and Symptoms of Medoroga	Before and After Treatment

Secondary Outcome Measures

Name	Time	Method
Improvement in the quality of life as assessed with the help of questionnaires for scaling of Quality Of Life (SF 36)	Changes in Body Mass Index, Skin Fold Thickness (Triceps and Abdomen) and Waist- Hip Ratio.

Trial Locations

Locations (1)

All India Institute Of Ayurveda; 🇮🇳 West, DELHI, India

All India Institute Of Ayurveda

🇮🇳West, DELHI, India

Dr Kirti Singhal

Principal investigator

8130074957

kirtisinghal72@gmail.com