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Clinical Trials/CTRI/2024/05/067161
CTRI/2024/05/067161Not yet recruitingPhase 3

An Open Labelled Active Controlled Randomized Clinical study to evaluate the efficacy of Herbal formulation in the management of Dyslipidemia

Parul Institute of Ayurved1 site in 1 country60 target enrollmentStarted: May 17, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Comparision of effect of Herbal formulation with statin in patients of dyslipidemia

Study Overview

Brief Summary

Lipids, such as cholesterol or triglycerides, are absorbed from the intestines and are carried throughout the body via lipoproteins for energy, steroid production, or bile acid formation. Major contributors to these pathways are cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein (HDL). An imbalance of any of these factors, either from organic or non-organic causes, can lead to Dyslipidemia. Dyslipidemia is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density lipoprotein (HDL). This condition can result from diet, tobacco exposure, or genetic. it can lead to cardiovascular disease with severe complications. In the list of WHO for lifestyle disorders, cardiovascular diseases take the lives of 17.9 million people every year, 31% of all global deaths. Dyslipidemia is a disorder of lipoprotein metabolism, which can include overproduction or deficiency of lipoprotein or both. Dyslipidemia can be due to familial disorders as well. Autosomal dominant mutations cause most cases of familial hypercholesterolemia in LDL receptors, which causes an elevation in LDL-C levels. The physical exam is limited in Dyslipidemia disorders. Xanthomas are deposits of lipids on the skin and sometimes subcutaneous tissue. They are yellowish and can form into plaques, nodules, or plaques. They can present on the palmar crease, which suggests familial dysbetalipoproteinemia, eyelids, or tendons. They typically are associated with hyperlipidemia, and if seen, the patient should have screening for Dyslipidemia. Various terminologies are used for Dyslipidemia like, Rasagata Sneha-vriddhi, Raktagata**Sneha vriddhi,Medo vriddhi,Medo-roga orMedo-dosha, Ama Medo dhatu and Kapha Medo Margavarana. But none of this term completely denotes Dyslipidemia. In such conditions, Charaka has mentioned that there can be no definite standardization of nomenclature of all diseases. The abnormalities in plasma lipoproteins are major risk factor for atherosclerosis. Hypercholesterolemia is directly proportional to atherosclerosis and ischemic heart disease. High cholesterol rarely showing symptoms, usually it is detected during routine blood test. Familial hypercholesterolemia may have distinct symptoms such as deposits of excess cholesterol that collect in the skin or eye tissue. Nodules in tendons in the hands or feet or rarely streaks in the hands are some other cholesterol deposits. Xanthomatosis  are yellow coloured, painless nodular masses on the body. Xanthelasma are yellowish plaques like lesions seen on the medial aspect of upper and lower eyelids, but also seen in normal individuals. Corneal arcus are greyish ring will appear along the periphery of cornea, but also seen in normal individuals.  Baddha meda ( bounded / unmovable ) are the fat which is not mobile and is stored in the form of fat at various places ( fat deposits/ omentum / muscle in the body ). Abaddha meda ( unboundable /movable ) are the fat which is mobile and circulate in the body along with in the form of lipids ( cholesterol , triglycerides , LDL , HDL , VLDL etc ).Prevalence of high cholesterol is 25–30% in urban and 15– 20% rural subjects and epidemiological studies have established a strong correlation between Premature Coronary Artery Disease / Cardiovascular disease and serum cholesterol levels. In general studies show that for each 1mg/dl decrease in LDL cholesterol in the plasma, there is about 2 percent decrease in mortality from atherosclerotic cardiovascular diseases. Therefore, appropriate preventive measures are valuable. Atorvastatin, Rosuvastatin used for treatment of Dyslipidemia, but they have side effect like elevated Transaminases, Myalgias, Arthralgias, Dyspepsia, Bloating, GI upset, Elevated Glucose, Elevated uric acid, Elevated liver function tests. Long term statin induced type 2 DM. International lipid panel- 2015 statin intolerance. Hence it is need of the day to find Ayurvedic remedy (herbal medication) for Dyslipidemia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients of either gender between age 18 and 70 years (both years inclusive) 2.Patient having one or more abnormal lipid level in lipid profile investigation 3.Patients with BMI from 18.5 to 40 Kg/㎡.

Exclusion Criteria

  • 1.Patients have other disease such as uncontrolled diabetes mellitus and hypertension.
  • 2.Dyslipidemia due to drugs e.g., glucocorticoids.
  • 3.Patients have history of MI, heart failure, stroke in last 6 months.
  • 4.Pregnant And lactating women.
  • 5.Patients who are currently participating in any other clinical trials(since last 2 months).
  • 6.Immunosuppressive patients –HIV.
  • 7.Patients with infective diseases- active tuberculosis, hepatitis B.

Outcomes

Primary Outcomes

Comparision of effect of Herbal formulation with statin in patients of dyslipidemia

Time Frame: Baseline,Day 15,Day 30,Day 45,Day 60,Day 75,Day 90

Secondary Outcomes

  • Compare the efficacy of herbal formulation with statin on Lipid profile, LFT,RBS(Compare the efficacy of Herbal formulation with statin on subjective criteria of Dyslipidemia)

Investigators

Sponsor
Parul Institute of Ayurved
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Vidhi Maheshkumar Desai

Parul Institute of Ayurveda

Study Sites (1)

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