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CTRI Number  CTRI/2025/03/081799 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of body Fat(meda dhatu) in Different Deh Prakriti Assessed by lipid profile 
Scientific Title of Study   Physiological study of meda dhatu in different deha prakriti with special reference to lipid profile. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajval maroti Selokar 
Designation  MD Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan  
Address  PG Department of Kriya Sharir,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-110073

New Delhi
DELHI
110073
India 
Phone  9766134887  
Fax    
Email  prajvalselokar2222@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof.(Dr) M.B.Gaur 
Designation  HOD, PG Department of kriya sharira 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan  
Address  PG Department of Kriya Sharir,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-110073

New Delhi
DELHI
110073
India 
Phone  9968838331  
Fax    
Email  manubhaigaur@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Prajval maroti Selokar 
Designation  MD Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan  
Address  PG Department of Kriya Sharir,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-110073

New Delhi
DELHI
110073
India 
Phone  9766134887  
Fax    
Email  prajvalselokar2222@gmail.com  
 
Source of Monetary or Material Support  
Department of kriya sharira Chaudhary Brahm prakash Ayurved Charak Sansthan,khera Dabar Najafgarh New Delhi-110073 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan  
Address  PG Department of kriya sharira Chaudhary Brahm Prakash Ayurved Charak Sansthan, khera dabar, New Delhi-110073 
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 Prajval Maroti Selokar  Ch. Brahm Prakash Ayurved Charak Sansthan  Ch. Brahm Prakash Ayurved Charak Sansthan and regions around South west Delhi
South West
DELHI 
9766134887

prajvalselokar2222@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 
Healthy Human Volunteers  Apparently Healthy Individuals 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-NIL (Procedure Reference: NIL, Procedure details: NIL)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. A person having no history of any apparent disease.
2.Person between ages 20-60 years.
3. Person having BMI upto 25.
4. Person irrespective of caste, religion, sex, economic status. 
 
ExclusionCriteria 
Details  1. Person having BMI above 25.
2. Age of patient less than 20 years and more than 60 years.
3. Individuals suffering from Diabetes mellitus, Hypertensioin and Heart diseases. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Association between meda dhatu and dehaprakriti will be observed. 
2.Association between meda dhatu and lipid profile will be checked.
 
12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
the prevalence obesity,atherosclerosis,hypercholesteromia,fatty liver disease was found to be high in India,medadhatu is basic causative factor for obesity & other lifestyle disorder.thus assessment of prakriti will be helpful for reduction in obesity.  12 Months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   01/04/2025 
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)   Not Applicable 
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  
           INTRODUCTION:

           In Ayurveda, Shareera depends on three basic entities to survive: Dosha, Dhatu, and Mala. Dhatu is one of these entities. Even though all individuals are composed of the same basic elements (Dosha, Dhatu, and Mala), differences between individuals can be seen in both the structural and functional elements based on several variables. After the action of Jatharagni on food to form ahara Ras, Dhatu divides the ahara Rasa into Saara and Kitta Bhaga only after completing Dhatu Parinama Kriya. Dhatu fulfills the roles of Dharana (structural framework) and Poshana Karma (nutritional pool). Qualitative, quantitative, and functional assessment of all dhatus is called dhatu sarata, or tissue excellence. Physical as well as mental strength can be assessed by examining the sarata of every dhatu.According to the San English dictionary, medas is marrow or fat in the body. Lipid is a Greek word derived from lipos, which means fat. Meda dhatu is the body component that indicates fat in general and adipose tissue in particular. Meda Dhatu is fourth among seven dhatus. It is derived from the root “Jhimida Snehana," which stands for sneha, fat, oil, etc. It means the substance that has Snigdhatva properties is called Medas. An important function of Meda dhatu is to oleate or lubricate [snehana].The term “Prakriti” refers to an individual’s genetically determined physical and mental composition. The relative significance of the three doshas, the basic five elements, and the characteristics of the ovum (Shonita) and sperm (Shukra) at the time of conception determine each particular prakriti. Each person is unique in their own way. Their constitution is one of the first known principles of preventative and personalized medicine and governs their biological activities, reactions to medications, environmental factors, and vulnerability to diseases. The Ayurvedic medical system’s proficiency with Prakriti and its capacity to categorize people according to their main Prakriti constitute some of its most significant and distinctive specializations and indispensable tools. The doshas predominance will be reflected in each and every aspect of the individual; it also influences Saara. Thus, the Prakriti of an individual gives a pool of information about the individual.

        RESEARCH QUESTION

          How does the lipid profile vary among individuals with different dehprakriti in the context of meda dhatu, and what specific lipid parameters show significant differences?

          NULL HYPOTHESIS (HO) 

          There is no significant difference in lipid profile among individual with distinct dehprakriti.

ALTERNATE HYPOTHESIS(HA)

There is significant difference in lipid profile among individual with distinct dehprakriti.
     AIM OF THE STUDY

         To study the meda dhatu in different dehaprakriti with special reference to lipid profile.

OBJECTIVE

    1.To establish association between medadhatu and dehprakriti.

2. To check association between medadhatu and lipid profile.

3.To find level of HDL (high density lipoprotein) than that of Total cholesterol and LDL (low density lipoprotein) in healthy individual.

MATERIALS AND METHODS

1.     STUDY TYPE: observational cross sectional study

2.     STUDY DURATION: 12month

3.     STUDY CENTRE: Ch. Brahm Prakash Ayurved Charak Sansthan, and region around south west Delhi.

4.     STUDY POPULATION: individual of age group 20-60years

5.     SAMPLE SIZE: 300

    Margin of error :5%

    Confidence level: 95%

    Population size:1500

    Response distribution :50%

INCLUSION CRITERIA

1.     A personwho have no history of any apprent disease.

2.     Person between ages 20-60 years.

3.     Person having BMIup to 25.

4.     Person irrespective of caste,religion, sex, economic status.

 

 EXCLUSION CRITERIA

1. Persons having  BMI above 25.

2. Age of patient less than 20 years and

more than 60 years.

3. Individuals suffering from Diabetes mellitus, Hypertension and heart diseases.

4. Individualsalready having deranged lipid profile or taking drugs like Atorvastatin, omega 3 fatty acids.

ASSESSMENT CRITERIA

1.Medodhatu assessed on basis of  body weight, BMI, lipid profile.

2.Prakriti of participant is assessed by self assessment of questionaire to determine prakriti.


PLAN OF STUDY

Prakriti of participant will be analyzed by self assessment questionnaire to determine prakriti.(SAQDP) and abaddha Medadhatu will be correlated circulating lipid and analyzed by lipid profileThe finding will be compiled and relation between medadhatu and prakriti will be analyzed with relevant statistical method.The data will be submitted in the form of thesis.

OUTCOME OF STUDY

PRIMARY OUTCOME

Association between meda dhatu and dehaprakriti will be observed. 

The association between meda dhatu and lipid profile will be checked.

SECONDARY OUTCOME

Different Prakriti are believed to have varying propensities for the accumulation and distribution of Medodhatu, impacting aspects like body shape, metabolism, and susceptibility to certain health conditions. Ayurveda considers this interplay when providing personalized health recommendations based on an individual’s Prakriti.

Obesity, atherosclerosis, hypercholesterolemia, fatty liver diseases, etc are caused due to defective metabolism of meda dhatu, The prevalence of abdominal obesity(sthulyata) was found to be high in India. overall,40% of women 12% of men are abdominally obese in the country. And medadhatu is basic causative factor for sthulyata and lifestyle disorders. Thus by assessment of Prakriti is helpful for a reduction in obesity.

Individuals with a predominant Kapha constitution are believed to have a natural tendency towards higher levels of Meda Dhatu. - Balancing the Meda Dhatu in individuals with a Kapha constitution involves dietary modifications, lifestyle changes, and herbal remedies to maintain optimal weight and overall health.

Individuals with a predominant Pitta constitution may have a moderate level of meda  dhatu based on their metabolic tendencies. Proper management of Meda Dhatu in Pitta-dominant individuals involves cooling and soothing dietary choices, stress management, and lifestyle adjustments to prevent inflammatory conditions.

Those with a predominant Vata constitution may struggle to maintain healthy levels of Meda Dhatu due to their naturally dry and mobile nature. Managing Meda Dhatu in Vata-dominant individuals involves incorporating nourishing and grounding foods, and establishing regular routines, and practices that promote stability and nourishment.


 
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