| CTRI Number |
CTRI/2024/12/077865 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the relationship between Rasasarata and Anxiety in Higher Secondary students. |
|
Scientific Title of Study
|
An observational study to find relation between Rasasarata and Anxiety in Higher Secondary students. |
| 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 Anuja Dadasaheb Kudale |
| Designation |
Pg Scholar |
| Affiliation |
Department Of Kriya Sharir Ground Floor College Of Ayurveda And Research Centre |
| Address |
Department Of Kriya Sharir Ground Floor College Of Ayurveda And Research Centre Sec 25 Nigdi Pradhikaran Pune India Maharashtra 411044.
Department Of Kriya Sharir Ground Floor College Of Ayurveda And Research Centre Sec 25 Nigdi Pradhikaran Pune India Maharashtra 411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9767312241 |
| Fax |
|
| Email |
anukudale7174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta More |
| Designation |
ASSO.PROFESSOR AND GUIDE |
| Affiliation |
PDEAs college of ayurveda and research centre |
| Address |
Kriya Sharir department ground floor PDEAs College of ayurveda and Reaserch centre Nigdi Pune India
Pune
MAHARASHTRA
411044
India |
| Phone |
9730473931 |
| Fax |
|
| Email |
shwetmore85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Dadasaheb Kudale |
| Designation |
PG SCHOLAR |
| Affiliation |
PDEAs college of ayurveda and research centre |
| Address |
Kriya Sharir department ground floor PDEAs College of ayurveda and Reaserch centre Nigdi Pune India
Pune
MAHARASHTRA
411044
India |
| Phone |
9767312241 |
| Fax |
|
| Email |
anukudale7174@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Center, Nigdi Pradhikaran, Pune, Maharashtra 411044, India. |
|
|
Primary Sponsor
|
| Name |
Dr Anuja Dadasaheb Kudale |
| Address |
Department of Kriya Sharir Ground Floor PDEAs College of Ayurveda and Research Center Sec 25 Nigdi Pradhikaran Pune Maharashtra 411044 India. |
| 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 Anuja Dadasaheb Kudale |
PDEAs College Of Ayurveda And Research Centre |
Department Of Kriya Sharir Ground Floor PDEAs College Of Ayurveda And Research Centre Sec 25 Nigdi Pradhikaran PUNE Mharashtra India 411044
Pune
MAHARASHTRA |
9767312241
anukudale7174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEA S College Of Ayurveda And Research Centre Nigdi Pradhikaran Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HIGHER SECONDARY STUDENTS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
-Students of higher secondary irrespective of gender.
-AGE -16-18years |
|
| ExclusionCriteria |
| Details |
Known case of psychological disorder.
k/c/o any chronic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find Relation Between Rasa Sarata And Anxiety In Higher Secondary Students |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
10/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Anxiety is common mental health condition that can affect individuals of all ages by examining the correlation between Ras sarta and anxiety in higher secondary students will help us to gain understanding for interaction and potentiality with the help of questionnaire and Hamilton scale of anxiety will help tailored interventions and treatment strategy according to AyurVed for young age group . |