| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 Vriddhi. According 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. |