| CTRI Number |
CTRI/2025/03/083748 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study Of Pranavaha Srotas of Different Body constitution Sthaulya individuals By Peak Flow Meter |
|
Scientific Title of Study
|
An Observational Study Of Pranavaha Srotas Parikshan in Sthaulya By Peak Flow Meter in Different Dehaprakruti. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Singh |
| Designation |
MD Scholar Kriya Sharir |
| Affiliation |
Dr D Y Patil college Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir, Dr.D.Y.Patil College Of Ayurveda And Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Maharashtra
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9074875799 |
| Fax |
|
| Email |
singhravindra6913@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Deshpande |
| Designation |
Assistant Professor Kriya Sharir |
| Affiliation |
Dr D Y Patil college Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir, Dr.D.Y.Patil College Of Ayurveda And Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Maharashtra
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8308840788 |
| Fax |
|
| Email |
vdkrishdeshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Deshpande |
| Designation |
Assistant Professor Kriya Sharir |
| Affiliation |
Dr D Y Patil college Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir, Dr.D.Y.Patil College Of Ayurveda And Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Maharashtra
411018
MAHARASHTRA
411018
India |
| Phone |
8308840788 |
| Fax |
|
| Email |
vdkrishdeshpande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College Of Ayurveda and Research Centre Sant Tukaram nagar Pimpri Pune Maharashtra India 411018
|
|
|
Primary Sponsor
|
| Name |
Ravindra Singh |
| Address |
Dr.D.Y.Patil College Of Ayurveda and Research Centre Sant Tukaram nagar Pimpri Pune 411018
|
| Type of Sponsor |
Other [] |
|
|
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 Krishna Deshpande |
Dr.D.Y.Patil vidyapeeth, Pimpri, Pune |
Dr.D.y.Patil vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA |
09074875799
singhravindra6913@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group- 18 years to 50 years.
Sex- male and female both.
Assessing the patient through subjective parameter (questionnaire for Sthaulya).
BMI equal or greater than 25. |
|
| ExclusionCriteria |
| Details |
Individuals with metabolic disorders like Thyroid, Diabetes melletus.
Individuals with disorders like COPD, Asthma etc.
Smoking individuals. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to find out the difference in peak expiratory flow rate in sthaulya (obesity) individuals |
1 day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the correlation between peak expiratory flow rate & deha prakriti |
1 day |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
10/04/2025 |
| 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="0"
Months="10"
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
|
Volunteers (both male and female) of age group 18-50 years will be taken on the basis of subjective parameters of sthaulya proforma and BMI equal to or more than 25 and onthropometric parameters (chest circumference, waist circumference, Hip circumference, waist to hip ratio) will be calculated. Prakruti assessment will be done on the basis of prakruti chart developed by kishore patwardhan. Selected volunteers will be than assesed with peak flow meter to determine peak expiratory flow rate. Data will be collected and statistical analysis will be done and conclusion will be drawn. |