Efficacy Of Loha Rasayana and Vyoshadi Saktu On Atherogenic Index Of Plasma (AIP) In Patients Of Metabolic Syndrome - An Open Labelled Randomized Comparative Clinical Trial.

Cardiovascular disease (CVD) is the cause of one-third of deaths worldwide and this status will progress because of increasing risk of CVD risk factors. The most important risk factors for CVD consist of Dyslipidemia, Hypertension, Obesity, Physical inactivity, poor diet, and smoking, which are the constituents of Metabolic Syndrome. Among these, plasma lipid profile is the major risk factor and predictor for CVD. Many clinical studies have made an effort to introduce a better marker of Atherogenic Dyslipidemia that can predict the risk of CVD, which is useful in evaluating response to treatment instead of the classical ratio. Atherogenic Index of Plasma (AIP) is a logarithmically transformed ratio of molar concentration of Triglycerides to HDL cholesterol. It has been shown that AIP is a strong marker in predicting the risk of Atherosclerosis and Coronary Heart Disease. AIP reflects the true relationship between protective and atherogenic lipoprotein and is associated with pre- and anti-atherogenic lipoprotein particle size. Contemporary treatment modalities concentrate on the treatment of the specific features of the conditions separately, with the overall goal of reducing the risk of cardiovascular disease and type 2 DM, but unfortunately patients end up with other complications due to the overburden of medications. There is an absolute need for a single noble strategy that can strike the ongoing disease pathology and reduce the burden upon the patient, and save the life from complications like Atherosclerosis and Coronary Heart Disease. Hence the current study attempts to evaluate the efficacy of trial drugs mainly on AIP which is the novel marker for Atherosclerosis and Coronary Heart Disease, especially in patients of Metabolic Syndrome as they are at high risk of developing CVD.

AIM: To assess the risk of Atherosclerosis and Coronary Heart Disease in patients with Metabolic Syndrome.

PRIMARY OBJECTIVE: To evaluate the efficacy of Loha rasayana in comparison to Vyoshadi saktu on the Atherogenic Index of Plasma

SECONDARY OBJECTIVE: To assess the changes in the Medoroga Lakshana, Anthropometric measurements, Single Indicators of MetS, Ankle-brachial index, HbA1c, C-reactive protein, Urinary microalbumin to creatinine ratio (ACR).

6.1.  STUDY TYPE: Open Labelled Randomized Comparative Clinical Trial

 

Study design

Pre and Post

|Purpose

Treatment

|Timing

Prospective

|End Point

Clinical Efficacy

|Masking

Open Label

|No. of groups

Two

|Sample size

80 (40 in each group)

|Duration of Trial

56 days

INCLUSION CRITERIA:

·       Age group 30-60 years irrespective of gender.

·       Patients fulfilling the Diagnostic criteria of Metabolic Syndrome.

·       Patients fit for Virechana Karma.

EXCLUSION CRITERIA:

·       Age group below 30 years and above 60 years.

·       Patients not fulfilling the Diagnostic criteria of Metabolic Syndrome

·       Uncontrolled Diabetes patients of (FBS >200mg/dl, PPBS >350mg/dl, HbA1C

10%)

·       Uncontrolled Hypertensive patients (BP> 170/100mm of Hg)

·       Patients under severe illness - Cardiovascular disorders, Encephalopathy, Tuberculosis, Chronic Renal and Liver disorders, Endocrine disorders like Cushing’s syndrome and other malignancies.

·       Patients unfit for Virechana Karma.

·       Pregnant women or willing-to-be pregnant or lactating mothers

·       Patients who are hypersensitive to any of the ingredients of trial drugs.

·       For any reason, the investigator may consider a subject inappropriate for participation in this study.

Total duration of trial (clinical trial duration + Follow-up duration) = 56days+42days = 98days Visit of patient during trial period on every 0,15,30,56 days. Follow-up will be done for 42 days after the intervention.