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CTRI Number  CTRI/2023/05/052340 [Registered on: 08/05/2023] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To evaluate the efficacy of eranda kshar yog and phaltrikadi yog in the management of medoroga w.r.t dyslipidemia 
Scientific Title of Study   A RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF “PHALTRIKADI YOGA”AND “ERANDA KSHAR YOGA” IN THE MANAGEMENT OF MEDOROGA W.S.R. TO DYSLIPIDEMIA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Yadav  
Designation  MD Scholar ( Kayachikitsa) 
Affiliation  A and U Tibbia College & Hospital 
Address  Room no. 6, Adamji Block, Department of Kayachikitsa, A and U Tibbia College & Hospital ,Karol Bagh, Delhi

Central
DELHI
110005
India 
Phone  9968969580  
Fax    
Email  abhiyadav221196@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujata Yadav 
Designation  Head of department  
Affiliation  A and U Tibbia College & Hospital 
Address  Room no. 6, Adamji Block, Department of Kayachikitsa, A and U Tibbia College & Hospital ,Karol Bagh, Delhi

Central
DELHI
110005
India 
Phone  9354925030  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sujata Yadav  
Designation  Head of department  
Affiliation  A and U Tibbia College & Hospital 
Address  Room no. 6, Adamji Block, Department of Kayachikitsa, A and U Tibbia College & Hospital ,Karol Bagh, Delhi

Central
DELHI
110005
India 
Phone  9354925030  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibia College Hospital 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibia College Hospital 
Address  Ayurvedic and Unani Tibbia College & Hospital ,Karol Bagh, Delhi-110005  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Yadav   Ayurvedic and Unani Tibia College Hospital  Room 6, PG department of Kayachikisa, Ayurvedic and Unani Tibbia College and Hospital ,Karol Bagh
Central
DELHI 
9968969580

abhiyadav221196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Ayurvedic and Unani Tibbia College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: PHALTRIKADI YOG, Reference: YOGRATNAKAR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: ERAND KSHAR YOG, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Manda), Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: PHALTRIKADI YOG, Reference: YOGRATNAKAR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
(2) Medicine Name: ERAND KSHAR YOG, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -manda), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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%)

 
 
ExclusionCriteria 
Details  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.
2) 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.


 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 



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

 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
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.)
 
3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 SantarpanjanyarogaAdhyaya“Medovriddhi or Medoroga, 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
 
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