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临床试验/CTRI/2024/02/063163
CTRI/2024/02/063163尚未招募3 期

Efficacy of Integrated Ayurveda Protocol in Dyslipidemia A randomized controlled clinical trial

DR ASHUTOSH1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Primary outcome will be based on Total cholesterol HDL ratio

研究概览

简要总结

Dyslipidemia is the imbalance of lipids such as cholesterol low-density lipoprotein cholesterol(LDL-C) triglycerides and high-density lipoprotein cholesterol(HDL-C) This condition can result from lifestyle factors tobacco exposure genetic and obesity can lead to cardiovascular disease with severe complications It is a prime reason for morbidity and mortality worldwide Abnormal cholesterol levels are estimated to cause 18% of the global CVDs (Cardiovascular diseases) and 56% of the global Ischemic Heart Diseases (IHD) For every 1% reduction in lipid level the risk of heart diseases reduces by 2.5% Dyslipidemia is an established risk factor for atherosclerotic diseaseAn estimated 17.9 million people died from CVDs in 2019 representing 32% of all global deaths Out of the 17 million premature deaths (under the age of 70) due to noncommunicable diseases(NCDs) in 2019  38% were caused by CVDs According to National Commission on Macroeconomics and Health (NCMH) a Government of India undertaking there is around 62 million patients with CVD in 2015 among which 23 million patients would be younger than 40 years of age In 2016 India reported 63% of  total deaths due to NCDs of which 27% were attributed to CVDs CVDs also account for 45% of deaths in the 40-69 year age group Despite considerable advances during the past 40 years there is increasing awareness among scientists epidemiologist and clinicians that current approaches to evaluate Coronary Heart Disease(CHD) risk in asymptomatic individual is sub optimal limiting HDL-C and LDL-C as therapeutic target Results of the Canadian cardiovascular  studies suggests that Total cholesterol to HDL ratio was better and cumulative marker for Dyslipidemia The total cholesterol/HDL ratio is a superior measure of risk for coronary heart disease compared with either total cholesterol or LDL cholesterol level Measurements of sdLDL size and LDL size have the potential to improve coronary disease risk assessment as well as decisions about LDL treatment intensity since they account for aspects of lipid atherogenicity that are incompletely reflected by values of LDL-C sdLDL size and non–HDL-C were more closely associated with the occurrence of future CAD than levels of LDL-C Whereas sdLDL size was related to CAD risk There is no direct reference of dyslipidemia in Ayurveda but the pathophysiology and presentation of dyslipidemia can be correlated to that of Medoroga Atisthoulya In comprehensive Ayurveda literature medoroga has been synonymously defined to Sthaulya Only Adhamalla while mentioning on sharangdhara samhita tried to differentiate between the two types of medo roga 1 Medo roga adiposity including its clinical features (Sthaulya) 2 Medo dosha lipid disorders where meda acts as an etiological factor in the genesis of other diseases The conventional drug therapy has limitation as lipid lowering drugs like statin and fibrates cause Myalgia increase blood glucose level Insulin Resistance headache dizziness digestive system problems when used for longer duration and in high doses So there is a need of alternate and safer therapies with fewer or no side effects Various studies on Ayurveda medications herbs shown results in  dyslipidemia Mostly drugs are Amala Tikta Kashaya and Katu in Rasa Laghu and Ruksha in Guna and Katu and Amala in Vipaka and thus pacifies the vitiated Kapha Dosha which is dominant in the pathogenesis of dyslipidemia It also depletes the excessively produced Rasa Mamsa Meda Vasa Sweda and Kleda which are all similar in attributes to Kapha Dosha Hence herbal formulations proved to have a better effect in dyslipidemia Diet has been recognized as playing a key role in the control of noncommunicable chronic diseases Specific foods and food components emerge as potential adjuvant strategies in the reduction of the risk of dyslipidemia Food components were revealed to act upon the different metabolic pathways that influence lipid disorders in humans They are believed to have the potential to ultimately become prominent in the future treatment and primary prevention of dyslipidemias and thereby in the control of CVDs The improvement in lipid profile with practice of  physical activity could be due to increased hepatic lipase and lipoprotein lipase This would increase the uptake of triglycerides by adipose tissue and affect the lipoprotein metabolism Vrikshamla (Garcinia indica Linn) has various pharmacological activities including antioxidant anti-obesity  anti-inflammatory hepatoprotective cardioprotective These characteristics are consistent with the previously reported activity of abundant phytochemical components such as garcinol HCA cyanidin-3-sambubioside and cyanidin-3-glucoside isolated from Vrikshamla (Garcinia indica Linn) These studies suggest the potential of Vrikshamla (Garcinia indica Linn) as a promising therapeutic agent for controlling and preventing various diseases However given that most of the trials have been conducted either in vitro or in vivo further study at the clinical level is needed to establish the efficacy and safety of Garcinia indica in humans So far no comparative clinical study has been published using  conventional antidyslipidemic protocol and  Integrated Ayurveda protocol involving small dense LDL as an assessment parameter

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed subjects of Dyslipidemia not on any medications Subjects with Dyslipidemia (Total Cholesterol to HDL Ratio greater than or equal to 5 ) Patient with age group between 18 to 70.

排除标准

  • Patient who are diagnosed to have systemic disorders like diagnosed with Diabetes mellitus Uncontrolled Hypertension Systolic more than 140mmhg and Diastolic more than 90mmhg and any serious systemic illness Pregnant and Lactating women Drug induced Dyslipidemia Patient who are having a past history of Stroke MI Severe Pulmonary dysfunctions which interfere with the treatment.

结局指标

主要结局

Primary outcome will be based on Total cholesterol HDL ratio

时间窗: Baseline 90th days

次要结局

  • Secondary outcome will be based on Small dense LDL particles size Insulin resistance parameter (TG to HDL-C ratio) Very low density lipoprotein and Serum triglyceride levels Anthropometry and QoL- SF36(Small dense LDL particles size Insulin resistance parameter (TG to HDL-C ratio) Very low density lipoprotein and Serum triglyceride levels (baseline and 90th day))

研究者

发起方
DR ASHUTOSH
申办方类型
Other []
责任方
Principal Investigator
主要研究者

DR ASHUTOSH

KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR, BELAGAVI, KARNATAKA

研究点 (1)

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