To evaluate the efficacy of eranda kshar yog and phaltrikadi yog in the management of medoroga w.r.t dyslipidemia

Phase 2/3

Not yet recruiting

Conditions: Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,

Registration Number: CTRI/2023/05/052340

Lead Sponsor: Ayurvedic and Unani Tibia College Hospital

Brief Summary: 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 SantarpanjanyarogaAdhyayaâ€œMedovriddhiorMedoroga, 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,

â€¢pastedGraphic.pngSpecific Investigations :

- Lipid Profile

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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%).

Exclusion Criteria

1. 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.
1. 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.
4)Patients with uncontrolled diabetes mellitus and HbA1C >7% 5) Patients with evidence of malignancy.
6)Hypersensitivity to any of the trial drugs or their ingredients.
7)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.
9)Pregnancy and Lactating mother.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipid Profile-total cholesterol, LDL-C, HDL-C, Triglycerides	3 months

Secondary Outcome Measures

Name	Time	Method
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.)

Trial Locations

Locations (1): Ayurvedic and Unani Tibia College Hospital
🇮🇳
Central, DELHI, India
Ayurvedic and Unani Tibia College Hospital
🇮🇳Central, DELHI, India
Dr Abhishek Yadav
Principal investigator
9968969580
abhiyadav221196@gmail.com