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CTRI Number  CTRI/2024/11/077122 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A COMPARATIVE PHARMACOLOGICAL AND CLINICAL STUDY TO EVALUATE THE EFFICACY OF TEJAS YOGA AND MEDOHAR GUGGULU IN THE MANAGEMENT OF MEDODUSHTI W.S.R. TO DYSLIPIDEMIA 
Scientific Title of Study   A COMPARATIVE PHARMACOLOGICAL AND CLINICAL STUDY TO EVALUATE THE EFFICACY OF TEJAS YOGA AND MEDOHAR GUGGULU IN THE MANAGEMENT OF MEDODUSHTI W.S.R. TO 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  Masum Sharma 
Designation  PG Scholar 
Affiliation  Shri NPA Government Ayurveda College Raipur Chhattisgarh  
Address  Department of Kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8602013782  
Fax    
Email  masumsharma95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Aruna Ojha 
Designation  Professor and HOD of Kayachikitsa Department 
Affiliation  Shri NPA Government Ayurveda College Raipur Chhattisgarh  
Address  Department of Kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Manoj Kumar Dash 
Designation  Reader of Department of Rasa Shastra and Bhaisajya Kalpana 
Affiliation  Shri NPA Government Ayurveda College Raipur Chhattisgarh  
Address  Department of Rasa Shastra and Bhaisajya Kalpana Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8817708049  
Fax    
Email  drmanojkumardash@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010 
 
Primary Sponsor  
Name  Department of Kayachikitsa 
Address  Department of Kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010 
Type of Sponsor  Other [Government Ayurved 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 
Masum Sharma  Shri Khudadad Dungaji Ayurveda College and Hospital Raipur Chhattisgarh  OPD Number 2 and 18 and IPD in the Department of Kayachikitsa Shri Khudadad Dungaji Ayurveda College and Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
8602013782

masumsharma95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee   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: MEDOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Tejas Yoga, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water ), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Medohara Guggulu, Reference: Ras tantra sar sangrah medohara prakran, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water ), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age above 20 years and below 60 years.
Patient with abnormal value of Total cholesterol, Serum triglyceride, LDL, VLDL, HDL
A following range value was taken for diagnosis of Dyslipidemia.
S. Cholesterol 200-239 mg/dl or/and
S. Triglyceride 200-399 mg/dl or/and
S.L.D.L 130-159 mg/dl or/and
S.H.D.L more than 40 mg/dl 
 
ExclusionCriteria 
Details  Age below 20 year and above 60 years.
2. Liver cirrhosis
3. Liver failure
4. Ascites
5. Cancer
6. Nephrotic syndrome
7. Chronic renal failure
8. Tuberculosis
9. Patients having H/o – Serious cardiac disorder like MI or cardiac failure.
10. Pregnant female and lactating mothers.
11. Known cases of Immunocompromised state (AIDS), cancer, hepatitis myeloma etc.
12. Patients suffering from D.M. that were poorly controlled and uncontrolled hypertension.
13. Patients taking allopathic medication for dyslipidemia like statins, fibrates derivatives
along with ayurvedic medication or does not agree for only ayurvedic medication. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tejas yoga will be efficacious in the management of dyslipidemia  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Tejas yoga will be more efficacious than medohara guggulu in the management of dyslipidemia   1 year 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   31/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The growing challenges of modernization have resulted in human beings readjusting their
customary behaviour by modifying their dietary and lifestyle preferences. Fast foods, lack of
exercise, stress, and various addictions are some of the factors that are adversely impacting the
lifestyle of man in the 21st century.
In ayurveda Medodushti can be corelated with Dyslipidemia. A person having Avyayama,
Achinta, Diwaswapna, Atisnigdha, Madhura, Adhyashan, Atimatra Ahara and Beejaswabhava
leads to medovaha srotodushti.
In due course of time Srotorodha (Blockage) of medovaha srotas effect tissue metabolism
which leads to Medoroga and its associated disorders like Sthaulya, Prameha, Kushtha,
disorders of Ama, Napunsakata, Dysuria.
Aetiological factor like: high fatty diet (Snighdha, Guru, Pichhila) and Sedentary Lifestyles
(Cheshtadvesha, Asana sukha) may contribute to Medovruddhi, a Santarpanjanya vyadhi in
Ayurveda which finally leads to morbidity of Kapha Dosha and Medo Dhatu. Due to
Medodhatvagni Dushti excessive accumulation of abnormal Kapha and Meda occurs in various
Srotas in body.
Sama Kapha - Sama Meda present in Rasa-Raktavaha Srotasa results in obstruction to the
movement of Vata & Rakta through affected srotas, which finally ends up in disease
manifestation according to the site of affliction. The state of Sama Kapha and Sama Medodhatu
and its excessive presence, margavarana in Rasa-Raktavaha Srotasa is often compared with the
state of dyslipidemia.
The term ‘Dyslipidemia’ denotes disordered lipid metabolism. It is defined as the presence of
raised or abnormal levels of lipids and/or lipoproteins in the blood. Dyslipidemia may result
from inborn defects of lipoprotein production or metabolism; but in most cases, it is secondary
to an unhealthy lifestyle (e.g. excessive cigarette smoking or alcohol consumption), other
health disorders (e.g. obesity, diabetes, infection, and obstructive liver disease), or medication
(e.g. β blockers, steroids).
Dyslipidemia is the disorder which has been identified as a potential risk factor for many
diseases, including cardiovascular diseases, metabolic syndrome, and hypertension.
Dyslipidemia has drawn worldwide interest for its ability to participate in the pathology of
atherosclerotic diseases by its deposition in the walls of arteries. It is responsible for many
life threatening condition like coronary artery disease (CAD), Ischemic heart disease,
hypertension and stroke, which is an important cause of morbidity and mortality the world
over.
Worldwide, cardiovascular disease is now one of the most common cause of death. The large
number of cases get diagnosed of Dyslipidemia while evaluating the Lipid profile of the patient.
Epidemiological study predict that for each 1% reduction in lipid level, the risk of heart diseases
reduces by 2.5%.
In modern system of medicine, we have wide range of drugs like statins, resins, fibric acid
derivatives, nicotinic acid, etc. which are quite effective in normalising the lipid levels. But
they may cause some side effects like headache, nausea, bowel upset, rashes, sleep
disturbances, myalgia, liver damage etc.
Keeping in mind above facts, it can be said that the final purpose of management of
dyslipidemia is to stop the formation of Sama Kapha and Sama Meda and to clear the
Srotorodha and then re-establishing the normal movement of Vata. Hence, Tejas yoga having
Ushna, Tikshna, Katu, Kaphavata shamak and Srotoshodhaka properties was selected for
management of Medodushti (dyslipidemia), which can help to break the Samprapti or clear the
Ama, Kapha, and Meda and to clear the Avarana and then re-establishing the normal movement
of Vata can help to manage the symptoms of dyslipidemia.
In the present study two drugs were selected for comparison ,first one is Medohar guggulu the
standard drug which is already given on our text and 2nd formulation is Tejas yoga whose drugs
are selected on the basis of their effect on medodhatu and having hypolipidemic activity.
 
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