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临床试验/CTRI/2025/02/080795
CTRI/2025/02/080795尚未招募不适用

“A Randomized Controlled Clinical Study to Evaluate The Efficacy Of Bilwadi Kwath In management of Medovruddhi w s.r. to Hyperlipidemia

Dr VJD Gramin Ayurved Mahavidyalaya PaturTal Patur Dist Akola Maharashtra India1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Symptom like 1.Shwasadhikya

研究概览

简要总结

Now-a-days, the evolution of technology has reached a point, where pretty much anything is available at the one touch. Machines and smart gadgets have replaced manual labour . People have started preferring packed & junk food to fresh, home-cooked meals. But, this Modern life-style coming at a price and a relatively crucial one as that is ‘Health’, Which causes many serious mental and physical diseases like Hyperlipidemia , Diabetes mellitus, Hypertension, Coronary heart disease etc.

The Worldwide prevalence of ‘Hyperlipidemia’ is about 39,000 per 1,00,000 patients. The matter of fear is, as per the opinion of National Commission on Macroeconomics and Health (NCMH), a Government of India undertaking, there would be around 62 million patients with CAD (Coronary Artery Disease) due to ‘Hyperlipidemia’ by 2015 in India. According to GHO (Global Health Observatory) data of WHO, globally a third of Ischemic Heart Disease is attributed to High cholesterol.

As per the scientific description, an elevated concentration of Triglycerides with Cholesterol in Fasting Plasma is called ‘Hyperlipidemia’, which causes by the accumulation of large Lipo-protein particles, contain both Triglycerides and Cholesteryl Esters. Further, which divide into Primary and Secondary types. Primary Lipid-disorders are usually inherited, whereas Secondary acquired as a result of other medical-disorders, such as Hypothyroidism, Chronic Liver Diseases, Type-II Diabetes Mellitus,Nephrotic Syndrome and reactions due to excessive intake of some drugs (for e.g. Steroids or Thiazide group drugs etc.).

Lipids and Lipo-protein abnormalities are as a modifiable risk factors for Coronary Heart Diseases because of their influence on Atherosclerosis.

Under the management of Hyperlipidemia many drugs are famous in Modern medicine like Statins (Atorvastatin, Rosuvastatin etc.), Gemifibrozil, Ezetimibe, Benzafibrate etc., but adverse point of it is it develops Side effects like Dyspepsia, Headache, Myopathy, Myalgia, Abdominal pain etc. Therefore, It is a necessity to find out some human health friendly and cost-wise cheap formulations to eradicate this disease.

The basic causative factor behind Hyperlipidemia is ‘Diet’, rich in ‘Saturated Fat’ according to Modern medicine. While according to Ayurvedic terminology, food articles having properties like Madhura Rasa and Guru, Snigdha, pichchil or Abhishyandi gunas in higher percentage leads to Medovruddhi and can be correlated to hyperlipidemia.

The all above scenario encouraged us(Guide and me) to invent the new and safe Polyherbal drug ‘Bilwadi kwath’.The reason behind it is, the dravyas under this yog have ‘Tikta’ Rasas, ‘Ushna’ Viryas as well as ‘Katu’ Vipakas will definitely lead to expected Sampraptibhanga (break of pathophysiology) by their specific mode of action.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Patients suffering from Medovruddhijanya symptoms
  • patients serum total cholesterol Level 200-250mg/dl 3.patient having serum triglyceride Level 150-300mg/dl 4.patient having serum LDL cholesterol Level 130-160mg/dl 5.patient having serum VLDL cholesterol Level 30-4e0mg/dl 6.patient having serum HDL cholesterol Level 30-40mg/dl.

排除标准

  • 1.Age group having below 30 and above 70 years.
  • 2.Pregnant and Lactating mother 3.Patient having Diabetes Mellitus 4.Patient having history of Heart Disease or Renal Disease 5.Patient having Acute Complication like Coronary Heart Disease ,Hepatitis 6.Patient having disorder like Carcinoma etc.anywhere in the body.

结局指标

主要结局

Symptom like 1.Shwasadhikya

时间窗: Symptom like 1.Shwasadhikya | 2.Nidradhikya | 3.Shrama-Asamarthata | 4.Gaurava | 5.Balahinata

2.Nidradhikya

时间窗: Symptom like 1.Shwasadhikya | 2.Nidradhikya | 3.Shrama-Asamarthata | 4.Gaurava | 5.Balahinata

3.Shrama-Asamarthata

时间窗: Symptom like 1.Shwasadhikya | 2.Nidradhikya | 3.Shrama-Asamarthata | 4.Gaurava | 5.Balahinata

4.Gaurava

时间窗: Symptom like 1.Shwasadhikya | 2.Nidradhikya | 3.Shrama-Asamarthata | 4.Gaurava | 5.Balahinata

5.Balahinata

时间窗: Symptom like 1.Shwasadhikya | 2.Nidradhikya | 3.Shrama-Asamarthata | 4.Gaurava | 5.Balahinata

次要结局

  • Decrease in symptoms of Medovruddhijanya symptom and(1.Serum Total Cholesterol Level 200-250mg/dl.)

研究者

发起方
Dr VJD Gramin Ayurved Mahavidyalaya PaturTal Patur Dist Akola Maharashtra India
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sweeti Bhagwat Patil

研究点 (1)

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