| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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)”. |