| CTRI Number |
CTRI/2024/01/061048 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess Uchwasan karma of Udan Vayu in the high BMI individuals |
|
Scientific Title of Study
|
A cross sectional analytical study to evaluate relation between Medovruddhi and Uchwasan karma of Udan Vayu in the high BMI individuals with the help of peak flow meter |
| 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 Sanket Chatar |
| Designation |
PG Scholer |
| Affiliation |
PDEAs college of ayurveda research center Nigdi Pune |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8605800614 |
| Fax |
0 |
| Email |
sanketchatar05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Chobhe |
| Designation |
HOD and Professor |
| Affiliation |
PDEAs college of ayurveda research center Nigdi Pune |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9850716124 |
| Fax |
0 |
| Email |
swatichobhe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Chatar |
| Designation |
PG Scholer |
| Affiliation |
PDEAs college of Ayurveda research center Nigdi Pune |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8605800614 |
| Fax |
0 |
| Email |
sanketchatar05@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurveda and research center Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sanket Chatar |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Sanket Chatar |
PDEAs college of Ayurveda research center Nigdi Pune |
PDEAs college of Ayurveda research center Nigdi Pune Kriya sharir department ground floor sector 25 pradhikaran nigdi pune
Pune
MAHARASHTRA |
8605800614
0
sanketchatar05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs college of ayurvedic research akurdi pune Institution Ethics Committee I for Human Resource |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having BMI Greater than 25 and individuals having BMI 18.5-24.9
Non exercising high BMI individuals having age group 18 To 49 years irrespective of sex |
|
| ExclusionCriteria |
| Details |
Pregnancy
Acute or Chronic illness
lung Diseases, respiratory diseases like bronchial asthma, bronchiectasis, emphysema etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find relation between Medovruddhi and Uchhawasan Karma of Udanvayu in high BMI individuals when compared with normal BMI Individuals with the help of Peak Flow meter |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/01/2024 |
| 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="0"
Months="3"
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
|
Medovruddhi or Overweight is currently one of the alarming situations due to wrong diet, sedentary lifestyle and stress. BMI (body mass index) is a simple index of weight for height that is commonly used to classify overweight and in adults. In Ashtanga Hridaya, effect of Medovruddhi on Shvasana (Breathing) is described, which throws light on adverse relation between Medovruddhi and lung functions. Considering dramatic increase in the prevalence of overweight individuals, an attempt has been made to find is there any relation between Medovruddhi and Uchawasan Karma of Udan Vayu. According to Ayurvedic compendia with minimal work also, dyspnoea is found in the Medovruddhi individuals. So it’s a curiosity to find, whether Medovruddhi affects Uchhawasan Karma of Udan Vayu. |