clinical study to assess the effectiveness and safety of ayurvedic herbomineral drug "shivagutika" in management of high cholesterol.
- Conditions
- Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH,
- Registration Number
- CTRI/2017/05/008545
- Lead Sponsor
- Rajiv Gandhi University of Health Sciences
- Brief Summary
**NEED FOR THE STUDY**
Hyperlipidemia,hyperlipoproteinemia or dyslipidemia is the condition of abnormally elevatedlevel of any or all lipids and /or lipoproteins in the blood1.Epidemiological studies have established a strong correlation between prematurecoronary artery disease (CAD) ,cardiovascular disease (CVD) and serum cholesterollevels. National Commission on Macroeconomics and Health (NCMH) in India hasestimated that by 2015 approximately 62 million Indian patients will developCAD; out of this 23 million will be less than 40 years of age5.Theexcess burden of CAD among Indian subcontinent appears to be primarily due todyslipidaemia with a low prevalence of non-lipid factors (hypertension, smokingand obesity).
Conventionaltreatment principles has a risk of chronic toxic effects includingcarcinogenic, teratogenic, and mutagenic changes over a lifetime of use6. Most of these lipid lowering drugs arecontraindicated in patients with Chronic liver disease, severe renal failure,gout and gall bladder disease7.Hence there is a need for morenatural methods to control cholesterol levels.
Ayurvedaemphasizes various dietic regimens, panchakarma procedures, wide range ofherbal and mineral drugs in the management of medoroga. Shivagutikaisone of the herbomineral drug contexted in various ayurvedic classiscs for thetreatment 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 inexperimentalstudies on lipid profile ofhyperlipidemic albino rats. The above mentioned trial gives a potentialproof to conduct human clinical trials. Hence an attempt is being made to finda safe, cost-effective and a promising remedy against dyslipidemia.
**AIMS AND OBJECTIVES**
The primaryobjective of the study is to evaluate the effect of shivagutika on lipidprofile and Apo lipoprotein B in dyslipidemic patients.
Secondaryobjective is to evaluate safety through effect on liver function test and renalfunction test in dyslipidemic patients.
**METHODOLOGY**
Randomized, singleblind controlled clinical study of 45 days duration with pre and post testassessment. A minimum of 60 patients, irrespective of age, sex, religion, fulfilling the diagnostic criteria, willing togive written informed consent for participation in the trialwill be incidentally selected from OPDand IPD of Government Ayurveda Medical College and Hospital, Mysore and fromspecial camps conducted for the study. A detailed proforma will be speciallydesigned encompassing all the aspects of the disease to collect the data.
Patients will beassigned into two groups: Group A (control) and B (Test), with each groupconsisting minimum of 30 patients and will be diagnosed on the basis of thelipid profile, Apolipoprotien B measurement showing any one or more of thefollowing criteria.
Serumcholesterol >200 mg/dl
SerumTriglycerides >150 mg/dl
SerumLDL >130 mg/dl
SerumVLDL >40 mg/dl
SerumHDL <40 for male <30 for female
Ratioof HDL to Cholesterol >4.5
ApolipoprotienB >125mg/dl
**Inclusion Criteria:**
· Menand women aged more than 20 years and below 60 years
· Patientsfulfilling the diagnostic criteria
· Bothfresh and treated cases will be included(Flush out period of 7 days is maintained for treated cases)
**ExclusionCriteria:**
- 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:
| | | |
| --- | --- | --- |
| GROUP A
GROUP B
|DRUG
Tab Navaka guggulu
Tab Shivagutika
|DOSE
2gram per day in two equally divided dose.
2gram per day in two equally divided dose.
|DURATION
45days
45 Days
|ANUPANA
Water
Water
|ROUTE / MODE
Oral
Oral
|KALA (TIMINGS)
Morning and night- after meals
Morning and night- after meals
**Assesmentparameter**
- Assesment will be done by post test lipid profile, apolipoprotien B measurement.
- The assessment will be done before starting the treatment i.e. 0th day and after the completion of the treatment i.e. 46thday.
**Assesmentof safety**
- Liver function test, serum creatinine, blood urea will be done during 23rd day and after intervention i.e. 46thday.
**5.Statistical Method**
The data will becollected before & after intervention and assessed statistically by usingdescriptive statistics, paired sample‘t’ test. Analysis will be done by using Service Product for Statistical Solution(SPSS) for windows software.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 60
- 1.Patients fulfilling the diagnostic criteria.
- 2.Lipid profile, 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 3.Both fresh and treated cases will be included (Flush out period of 7 days is maintained for treated cases).
- 1.Patients having history of serious cardiac disorders like myocardial infarction, cardiac failure, etc.
- 2.Patients having any major illness, insulin dependent diabetes mellitus, Type II diabetes mellitus that is poorly controlled 3.Patients having a history of untreated thyroid disorder 4.Hyperlipidemia due to drugs (e.g., glucocorticoids) 5.Pregnant females and lactating mothers 6.Renal insufficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of shivagutika in dyslipidemia (lipid profile and on Apo lipoprotein B). Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention. To evaluate the effect of Navaka guggulu in dyslipidemia (lipid profile and on Apo lipoprotein B). Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention. To evaluate the safety of shiva gutika and Navaka guggulu. Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention. To compare the efficacy of shiva gutika with control drug Navaka guggulu. Lipid profile,Apolipoprotien B,Liver function tests will be performed before intervention and after 45 days of intervention.
- Secondary Outcome Measures
Name Time Method Safe and cost effective natural drug for managing dyslipidemia, prevention of coronary artery diseases. 0 day and 45th day
Trial Locations
- Locations (1)
Department of kayachikitsa,1st floor
🇮🇳Mysore, KARNATAKA, India
Department of kayachikitsa,1st floor🇮🇳Mysore, KARNATAKA, IndiaDr Gajanana HegdePrincipal investigator9448738936dr.hegdegajanana@gmail.com