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CTRI Number  CTRI/2025/03/082310 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Relationship between increased fat and respiration. 
Scientific Title of Study   Association between Meda Dhatu Vriddhi and Shwasan Kriya w.s.r.to Alpeapicheshtite Shwasam:A Cross Sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana Agrawal 
Designation  MD scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Room no 624 6th floor Department of Kriya Sharira Institute of Teaching and Research in Ayurveda Opposite B Division Police Station Gurudwara Road, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9090372818  
Fax    
Email  archuagrawal97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof A S Baghel 
Designation  Professor and HOD of Basic Principle 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Room no 303, 3rd floor Department of Basic Principle Institute of Teaching and Research in Ayurveda Opposite Reliance Smart Near B Division Police Station Gurudwara Road, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9426433575  
Fax    
Email  asbaghel@itra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Archana Agrawal 
Designation  MD scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Kriya Sharira Institute of Teaching and Research in Ayurveda Opposite B Division Police Station Gurudwara Road, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9090372818  
Fax    
Email  archuagrawal97@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda opposite reliance smart near B division police station gurudwara road Jamnagar Gujarat 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Opposite Reliance Smart Near B Division Police Station Gurudwara Road Jamnagar 361008 Gujarat 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 Archana Agrawal  Institute of Teaching and Research in Ayurveda  OPD no.C-16 Department of Kriya Sharira Institute of Teaching and Research in Ayurveda Opposite Reliance Smart Near B Division Police Station Gurudwara Road Jamnagar 361008 Gujarat India
Jamnagar
GUJARAT 
9090372818

archuagrawal97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Teaching and Research in Ayurveda, Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Body Mass Index (B.M.I.) above 24.9 kg/m2
2. Participants irrespective of gender, caste, religion, occupation.
3. Participants having symptoms of Alpeapicheshtite Shwasam and Sphik-stana- udaralambanam with other symptoms of Meda Dhatu Vriddhi.
4. Participants willing and able to participate in study.
 
 
ExclusionCriteria 
Details  1. B.M.I. below 24.9 kg/m2
2. Participants having pregnancy, Lactating women.
3. Participants having Dyspnea due to Asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary tuberculosis, other respiratory diseases and involvement of any systemic disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The evidence-based data generated through present study will be helpful in understanding the clinical importance of Meda Dhatu during health and disease state and its effect on respiratory health and physiology.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
The study will be helpful in spreading awareness among participants regarding their increased weight. It will motivate them to lead a healthy lifestyle.  1 Year 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/08/2025 
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:-

Meda Dhatu increases due to Avyayama, Diwaswapna, and intake of Kapha Vardhak Aahara. This excess of Meda and Kapha lead to Srotovarodha which leads to further Meda Dhatu VriddhiAccording to Acharya Vagbhatta Meda Dhatu Vriddhi causes fatigue, dyspnea on mild exertion, increase in the circumference of the buttock, breast and abdomen. Meda Dhatu Vriddhi results in Kapha Vriddhi due to Ashraya Ashrayee Bhava.

The Increased Kapha obstructs the Vata Dosha and Pranavaha Srotas which are involved in the process of respiration (Shwasan Kriya). Moolasthan of Pranavaha Srotas are Hridaya and Mahasrotas, which is also known as Ampakwashaya. Increased Meda Dhatu, results in   difficulty in breathing, indicating deposition of fat in abdominal muscles. 

Dyspnea on mild exertion present in Meda Dhatu Vriddhi indicates involvement of the Pranavaha Srotas.

Rationality of research topic:-

In this modern era, the widespread adoption of modern technology and the impact of COVID-19 has led to significant changes in diet, sedentary lifestyle, and daily routines which contributes to Meda Dhatu Vriddhi

Excess of body fat impacts on the respiratory system is often underestimated. It is associated with impairment of lung functions (Shwasan Kriya) mechanically. Impaired lung function in particular, low forced expiratory volume in 1s (FEV1) is associated with increased morbidity and mortality.

Excess of body fat has adverse effects on respiratory mechanics, resistance within the respiratory system, function of respiratory muscles, control of breathing, and gaseous exchange. Individuals with excessive body fat tend to be chronically hypoventilated even though most of them have anatomically intact pulmonary structures.

So, the present research topic has been selected to explore the effect of Meda Dhatu Vriddhi on airway health and respiratory physiology and to determine the association between the Meda Dhatu Vriddhi and Shwasan Kriya

Aim:

To find association between Meda Dhatu Vriddhi and Shwasan Kriya w.s.r. to Alpeapicheshtite Shwasam .

Objectives:

1)To understand the concept of Meda Dhatu Vriddhi.

2)To explore and understand the concept of Shwasan Kriya.

Material and Method: 

200 desired volunteer participants between age group of 20 to 50 years will be taken in survey study.

Results and Discussion: 

Data generated during the above study will be presented in a systemic manner as shall be analyzed, where the important points of the review of literature and data of survey study based on statistical analysis will be discussed.

 
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