NEED FOR THE STUDY

              Hyperlipidemia, hyperlipoproteinemia or dyslipidemia is the condition of abnormally elevated level of any or all lipids and /or lipoproteins in the blood¹. Epidemiological studies have established a strong correlation between premature coronary artery disease (CAD) ,cardiovascular disease (CVD) and serum cholesterol levels. National Commission on Macroeconomics and Health (NCMH) in India has estimated that by 2015 approximately 62 million Indian patients will develop CAD; out of this 23 million will be less than 40 years of age⁵.The excess burden of CAD among Indian subcontinent appears to be primarily due to dyslipidaemia with a low prevalence of non-lipid factors (hypertension, smoking and obesity).

Conventional treatment principles has a risk of chronic toxic effects including carcinogenic, teratogenic, and mutagenic changes over a lifetime of use⁶.  Most of these lipid lowering drugs are contraindicated in patients with Chronic liver disease, severe renal failure, gout and gall bladder disease⁷.Hence there is a need for more natural methods to control cholesterol levels.

Ayurveda emphasizes various dietic regimens, panchakarma procedures, wide range of herbal and mineral drugs in the management of medoroga. Shivagutika is one of the herbomineral drug contexted in various ayurvedic classiscs for the treatment of kaphamedoja vikara like prameha, medoroga, sthoulya, granthi, gulma, arbudha. The main ingredient of shiva gutika is shilajatu . Shiljatu has proven a significant effect against simvastatin in experimental studies on lipid profile of hyperlipidemic albino rats. The above mentioned trial gives a potential proof to conduct human clinical trials. Hence an attempt is being made to find a safe, cost-effective and a promising remedy against dyslipidemia.

AIMS AND OBJECTIVES

The primary objective of the study is to evaluate the effect of shivagutika on lipid profile and Apo lipoprotein B in dyslipidemic patients.

Secondary objective is to evaluate safety through effect on liver function test and renal function test in dyslipidemic patients.

METHODOLOGY

Randomized, single blind controlled clinical study of 45 days duration with pre and post test assessment. A minimum of 60 patients, irrespective of age, sex, religion,  fulfilling the diagnostic criteria, willing to give written informed consent for participation in the trial will be incidentally selected from OPD and IPD of Government Ayurveda Medical College and Hospital, Mysore and from special camps conducted for the study. A detailed proforma will be specially designed encompassing all the aspects of the disease to collect the data.

Patients will be assigned into two groups: Group A (control) and B (Test), with each group consisting minimum of 30 patients and will be diagnosed on the basis of the lipid profile, Apolipoprotien B  measurement showing any one or more of the following criteria.

Serum cholesterol >200 mg/dl

Serum Triglycerides >150 mg/dl

Serum LDL >130 mg/dl

Serum VLDL >40 mg/dl

Serum HDL <40 for male <30 for female

Ratio of HDL to Cholesterol >4.5

Apolipoprotien B >125mg/dl

Inclusion Criteria:

·         Men and women aged more than 20 years and below 60 years

·         Patients fulfilling the diagnostic criteria

·         Both fresh and treated cases will be included (Flush out period of 7 days is maintained for treated cases)

Exclusion Criteria:

• Patients having history of serious cardiac disorders like myocardial infarction, cardiac failure, etc.
• Patients having any major illness, insulin dependent diabetes mellitus, Type II diabetes mellitus that is poorly controlled
• Patients having a history of untreated thyroid disorder
• Hyperlipidemia due to drugs (e.g., glucocorticoids)
• Pregnant females and lactating mothers
• Renal insufficiency

       Investigations –

• Serum Lipid Profile (12 hr fasting blood sample), Apolipoprotein B is investigated as a biomarker for hyperlipidemia.

• Other Blood investigations – Hb %, TC, DC, ESR, RBS, to rule out other diseases.
• Blood Urea, Serum Creatinine, Liver function test, for safety assessment.
• Urine investigations - Urine Sugar, microscopic, albumin were done to rule out other systemic diseases or complications.

Intervention (Drugs and posology)

• The selected patients were randomly allocated into two groups as follows:

Assesment parameter

• Assesment will be done by post test lipid profile, apolipoprotien B measurement.
• The assessment will be done before starting the treatment i.e. 0^th day and after the completion of the treatment i.e. 46th day.

Assesment of safety

• Liver function test, serum creatinine, blood urea will be done during 23rd day and after intervention i.e. 46th day.

5. Statistical Method

The data will be collected before & after intervention and assessed statistically by using descriptive statistics, paired sample‘t’ test.  Analysis will be done by using Service Product for Statistical Solution (SPSS) for windows software.