| CTRI Number |
CTRI/2025/02/080335 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study to assess the efficacy of Nadishuddhi Pranayama in alleviating stress levels in degree college students with different sharir prakruti in Navi Mumbai region. |
|
Scientific Title of Study
|
A comparative clinical study to assess the efficacy of Nadishuddhi Pranayama in alleviating stress levels in degree college students with different sharir prakruti in Navi Mumbai region. |
| 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 Aditi Bhagat |
| Designation |
PG Scholar |
| Affiliation |
School of Ayurveda,D.Y Patil Deemed to be University Navi Mumbai |
| Address |
Department of Kriya Sharir
School of Ayurveda,D.Y Patil Deemed to be University,Nerul , Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
8788713913 |
| Fax |
|
| Email |
bhagatdraditi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangini Waghulade |
| Designation |
Professor and HOD |
| Affiliation |
DY Patil (Deemed to be University), School of Ayurveda, Navi Mumbai |
| Address |
Department of Kriya Sharir
School of Ayurveda,D.Y Patil Deemed to be University,Nerul,Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
8108518452 |
| Fax |
|
| Email |
hemangini.waghulade@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Bhagat |
| Designation |
PG Scholar |
| Affiliation |
DY Patil (Deemed to be University), School of Ayurveda, Navi Mumbai |
| Address |
Department of Kriya Sharir
School of Ayurveda, D.Y Patil Deemed to be University, Nerul, Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
8788713913 |
| Fax |
|
| Email |
bhagatdraditi@gmail.com |
|
|
Source of Monetary or Material Support
|
| The clinical materials required for stress and nadishuddhi pranayam will be screened and enrolled from students of School of Ayurveda,D.Y Patil Deemed to be University,Nerul ,Navi Mumbai , Maharastra India,400706 . |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Bhagat |
| Address |
Department of Kriya Sharir, School of Ayurveda , D.Y Patil Deemed to be University,Nerul,Navi Mumbai, Maharashtra ,India, 400706 |
| 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 Adit Bhagat |
D.Y Patil Deemed to be university School of Ayurveda |
Department of Kriya Sharir,School of Ayurveda,D.Y Patil Deemed to be University,Nerul,Navi Mumbai,Maharashtra ,India,400706
Mumbai
MAHARASHTRA |
8788713913
bhagatdraditi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DY Patil Deemed to be university School of Ayurveda, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students categorised in mild (40-80) and moderate (80-121) groups according to SSI (Student Stress Inventory) scale. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Nadishuddhi Pranayama., Pathya/Apathya:yes, Pathya:perform procedure 1.5 hours after breakfast., Apathya:None | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:No Nadishuddhi Pranayama. Only analysis., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects ready to abide by trial procedure and to give informed consent. |
|
| ExclusionCriteria |
| Details |
Below 18 years of age and above 25 years of age. having chronic or acute disease or any type of mental condition. Doing pranayama regularly. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress level analysis in different sharir prakruti of degree college students. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the efficacy of nadishuddhi pranayama in alleviating stress levels of degree college students |
90 days. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/02/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhagatdraditi@gmail.com].
- For how long will this data be available start date provided 24-02-2025 and end date provided 24-11-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per lottery method. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, DY Patil Deemed to be University School of Ayurveda, Navi Mumbai and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They will be divided into 2 groups and the trial is open randomised control clinical trial. The time period for the trial is 3 months. |