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CTRI Number  CTRI/2026/01/101004 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to evaluate on the efficacy of Ayurvedic intervention in Vidangadi Lauha and Trayushanadi Lauha with Phalatrikadi Kwath in MEDOROGA (DYSLIPIDEMIA)” 
Scientific Title of Study   “A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Vidangadi Lauha And Trayushanadi Lauha With Phalatrikadi Kwath In Medoroga (Dyslipidemia)” 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha Yadav 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Rajasthan 302002 India Jaipur RAJASTHAN 302002 India Jaipur RAJASTHAN

Sikar
RAJASTHAN
302002
India 
Phone  8619013638  
Fax    
Email  yadav.uvarsha85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR HARI MOHAN LAL MEENA 
Designation  PROFESSOR & HOD DEAN (UG studies) 
Affiliation  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Rajasthan 302002 India Jaipur RAJASTHAN 302002 India Jaipur RAJASTHAN

Sikar
RAJASTHAN
302002
India 
Phone  9461297017  
Fax    
Email  hari_mohan68@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR HARI MOHAN LAL MEENA 
Designation  PROFESSOR & HOD DEAN (UG studies) 
Affiliation  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Rajasthan 302002 India Jaipur RAJASTHAN 302002 India Jaipur RAJASTHAN

Sikar
RAJASTHAN
302002
India 
Phone  9461297017  
Fax    
Email  hari_mohan68@yahoo.co.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India Jaipur R 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer Rajasthan 302002 India 
Type of Sponsor  Research institution and hospital 
 
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 Varsha Yadav  Hospital, National Institute ofAyurveda, Deemed to be university, Jaipur  OPD No 1, 18, 22, 25, new OPD 1,2 Department of Kayachikitsa, NationalInstitute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India Jaipur Rajasthan Jaipur RAJASTHAN
Sikar
RAJASTHAN 
08619013638

yadav.uvarsha85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionalethicscommittee -Nationalinstitute ofayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vidangadi lauha , Reference: Bhaishajya Ratnavali, Medoroga Chikitsa, Chapter 39, Verse 22), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Phalatrikadi Kwath ), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Trayushnadi Lauha, Reference: Yogratnakar , Medorog Chikitsa Page no. 99, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Phalatrikadi Kwath ), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i)Adults in the age group of 18 to 60 years of either sex.
ii)LDLC more than and equal to 130 mg/dl and less than and equal to 190 mg/dl.
iii)Cholesterol more than and equal to 200 mg/dl and less than and equal to 300mg/dl.
iv)Triglycerides level more than and equal to 150 mg/dl and less than and equal to 300mg/dl.
v)Those who have voluntarily signed the written informed consent.
• If any one of the following criteria is met patient will be included .
 
 
ExclusionCriteria 
Details  i)Patients having history of angina, Myocardial infarction and cerebrovascular accidents.
ii)Patients having Systolic blood pressure (SBP) & Diastolic blood pressure (DBP) more than an equal to 160 &100 mm of Hg respectively.
iii)Patients with uncontrolled diabetes mellitus with FBS level more than 160 mg/dl or HbA1c higher than 8%.

iv)Patients having hypothyroidism with TSH level more than and equal to 1.5 times the upper limit of normal.
v)Patients having statins, fibric acid derivatives, cholestyramine, nicotinic acid, proprotein convertase subtilisin/kexin type 9 inhibitors, corticosteroids, diuretics, amiodarone, cyclosporine.
vi)Patients with chronic disorders like Nephrotic syndrome, Renal failure, Auto immune disorders, Chronic Liver Disease (AST or ALT levels more than 2 times the upper limit of normal), and other serious diseases
(vii)Pregnant women and lactating mother and females of child bearing age willing to conceive during trial period.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study will be the change in LDL-C levels from baseline to the end of the treatment period.  baseline to the end of the treatment period. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Blood levels of TC, HDL-C, TG, fasting blood glucose, TC:HDL-C, SGOT, SGPT, S.Creatinine.  baseline to the end of the treatment period. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   01/06/2026 
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="1"
Months="6"
Days="28" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dyslipidemia is a disorder of lipid metabolism characterized by abnormal levels of serum lipids, including elevated total cholesterol, low-density lipoprotein (LDL), triglycerides, and/or reduced high-density lipoprotein (HDL). It is a major modifiable risk factor for cardiovascular diseases such as coronary artery disease, stroke, and peripheral vascular disease. Clinically, dyslipidemia may remain asymptomatic for long periods, eventually manifesting through complications affecting the heart, brain, and vascular system.

India is witnessing a rapid rise in the prevalence of dyslipidemia due to changing lifestyle patterns, urbanization, unhealthy dietary habits, and reduced physical activity, making it a significant public health concern. Although conventional treatments such as statins and other lipid-lowering agents are effective, long-term therapy is often associated with adverse effects, poor compliance, and economic burden. This highlights the need for exploring safe, effective, and sustainable alternative treatment modalities.

Ayurvedic management of dyslipidemia has shown promising results in improving subjective symptoms and lipid parameters; however, many studies report limitations such as small sample size and lack of comparative evaluation. Therefore, a systematic clinical assessment using appropriate study design is essential to establish evidence-based efficacy.keeping all these facts in mind, it has been decided to conduct a clinical study entitled as" A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDANGADI LAUHA AND TRAYUSHANADI LAUHA WITH PHALATRIKADI KWATH IN  MEDOROGA (DYSLIPIDEMIA)”.

 
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