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临床试验/CTRI/2023/05/052340
CTRI/2023/05/052340尚未招募2/3 期

A RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF “PHALTRIKADI YOGAâ€AND “ERANDA KSHAR YOGAâ€Â IN THE MANAGEMENT OF MEDOROGA W.S.R. TO DYSLIPIDEMIA

Ayurvedic and Unani Tibia College Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Lipid Profile-total cholesterol, LDL-C, HDL-C, Triglycerides

研究概览

简要总结

In the era of urbanization, Dyslipidemia has emerged as a serious health issue of both developed and developing nations and recognized as a serious public health problem of the 21st century. It is recognized as one of the important lifestyle and metabolic disorders. It is a leading preventable cause of death world over. In the world of modern era, sedentary life-style and drastic alteration in food intake are leading cause of the non-communicable disease such as Dyslipidemia, Type-2 Diabetes Mellitus (DM), Hypertension and Obesity, which are closely linked with each other and often co-exist in individual making the syndrome, more complex and difficult to manage. Dyslipidemia means abnormal (increased or decreased) values of serum cholesterol, serum triglycerides, serum VLDL and decrease in HDL level.

It is a disorder of lipoprotein metabolism which can include overproduction or deficiency of lipoprotein or both. The disorder can manifest as an elevation of plasma cholesterol, triglycerides or both, or a low high -density lipoprotein level. Abnormalities of various cholesterol lipoprotein lipids such as high total cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides and low high density lipoprotein(HDL) cholesterol are important coronary heart disease (CHD) risk factors. There is a strong pathophysiological association of raised LDL cholesterol with initiation and progression of coronary atherosclerosis. Robust data are available that shows that lowering its levels can regress and stabilize atherosclerotic vascular disease. It is not a single condition

but a range of disorder with a variety of genetic and environmental

determinants.

The conventional concept of etio-pathogenesis, prognosis, and management of Dyslipidemia is very similar and equally advanced to the Medoroga of Ayurveda, which was conceived by Acharya Charaka. In Ayurveda, Lipids as explained in modern sciences has close resemblance with Sneha Dravya in Ayurveda i.e. Meda, Vasa. Meda is the 4thDhatu out of seven, whose function is to provide Sneha to the body.

Meda = Prithvi + Aap Mahabhoot, it is characterized by Snigdha, Guru, Sthula, Picchila, Mridu, Sandra guna. Sneha, Sweda, Drudhatva (compactness) and Asthipushti are main functions of Medo Dhatu. According to Ayurveda,Nidana for Medoroga is excessive intake of ShleshmaVardhakaAhara- Vihara and less exercise causes Agnidushti resulting in excessive formation of Sama Meda. Due to AvaranaofMarga by the Sama Meda, Poshana of subsequent Dhatu in the body is hampered leading to Upachaya of Medodhatu.Medodhatvagnimandya leads to improper formation of Medodhatu in excess and if not arrested further results in Medoroga. According to Madhav Nidana, Medoroganidana Adhyaya &Charaka Samhita Sutrasthana SantarpanjanyarogaAdhyaya“MedovriddhiorMedoroga, Medorogajanyasigns & symptoms show strikingly resemblance with Dyslipidemia explained in modern text. Dyslipidemia can be included under Santarpanajanya Vyadhi as Medoroga.

LABORATORY INVESTIGATIONS

Routine Investigations :

Investigations will be done before starting the therapy and at completion of trial. Assessment of the therapy will be done by evaluating their value before and after completion of trial.

pastedGraphic.png Haematological investigation-

  • Haemogram ( Hb,TLC,DLC,ESR,PLATLET COUNT)
  • Blood sugar -random

BiochemicalInvestigations-

  • LFT,
  • KFT,
  • Urine - routine & microscopy,

•pastedGraphic.pngSpecific Investigations :

  • Lipid Profile

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • a) Patients between the age group of 18-60 years of either sex.
  • b) Willing and able to participate in the study for 90 days.
  • c) Patients having Serum Cholesterol 201-400mg/dl, Serum Triglycerides 151- 400 mg/dI LDL Cholesterol 131-250 mg/dl, HDL Details Cholesterol <40mg/dI.
  • d)Patients with strictly controlled Diabetes Mellitus (HbA1c less than or equal to 7%).

排除标准

  • Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, congestive heart failure ,Stroke or severe Arrhythmia, Unstable angina in the last six months.
  • Patients on prolonged (>6weeks) medication with corticosteroids, antidepressants, anti cholinergics, immunosuppressant 3) Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mm of Hg) despite of antihypertensive agents.
  • Patients with uncontrolled diabetes mellitus and HbA1C >7% 5) Patients with evidence of malignancy.
  • Hypersensitivity to any of the trial drugs or their ingredients.
  • Patients who have completed participation in any other clinical trial drugs or their ingredients in one month 8)Patients who have received any cholesterol lowering medication (allopathic drug) within last two weeks.
  • Pregnancy and Lactating mother.

结局指标

主要结局

Lipid Profile-total cholesterol, LDL-C, HDL-C, Triglycerides

时间窗: 3 months

次要结局

  • A detailed evaluation of biochemical investigations(Hemogram ,RBS,Urine- routine and microscopic examination.,Kidney Function tests,Liver function tests(will be repeated at the end of the study.))

研究者

发起方
Ayurvedic and Unani Tibia College Hospital
申办方类型
Government medical college

研究点 (1)

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