| CTRI Number |
CTRI/2024/10/075966 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Group counselling] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of combined treatment including aswagandha, ayurvedic psychotherapy and yoga in the anxiety before competition of judo players |
|
Scientific Title of Study
|
Effectiveness Of Integrated Protocol In Competitive Anxiety Among Judo Players - Single Group Pre-Test Post-Test Design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joyal L Joy |
| Designation |
MD Scholar |
| Affiliation |
VPSV Ayurveda college, Kottakkal |
| Address |
Department of kayachikitsa,
VPSV Ayurveda college, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
8289831209 |
| Fax |
|
| Email |
joyalljoy333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Joyal L Joy |
| Designation |
MD Scholar |
| Affiliation |
VPSV Ayurveda college, Kottakkal |
| Address |
Department of kayachikitsa,
VPSV Ayurveda college, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
8289831209 |
| Fax |
|
| Email |
joyalljoy333@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joyal L Joy |
| Designation |
MD Scholar |
| Affiliation |
VPSV Ayurveda college, Kottakkal |
| Address |
Department of kayachikitsa,
VPSV Ayurveda college, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
8289831209 |
| Fax |
|
| Email |
joyalljoy333@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Joyal L Joy |
| Address |
Department of Kayachikitsa VPSV Ayurveda college, Kottakkal
Malappuram
Kerala
676501 |
| 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 Preetha PR MS Ay |
Kerala Institute of Sports Ayurveda Research, Thrissur |
Rooom 3
Marma OP
Kerala Institute of sports Ayurveda Research
Palace Road, Opp. Co-Operative College,
PO Thiruvambady, Thrissur- 680022
Thrissur
KERALA |
8848590189
preethapr40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: aswagandha, Reference: bhavaprakasha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 600(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Those having mild – moderate competitive anxiety ie. 17- 24 score as per Sports Competition Anxiety Test (SCAT) questionnaire
Those providing informed consent
|
|
| ExclusionCriteria |
| Details |
Newly recruited judo players (less than 1 year of training)
Suffering from sports injuries and other systemic illness
History of psychiatric illness and / on psychiatric medication.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess the effectiveness of the integrated protocol in competition anxiety among the judo players. |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of the integrated protocol on the participant’s psychological performance.
To assess the effectiveness of the integrated protocol on perceived stress among the participants. |
31 days |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="1"
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
|
For
this study we selected 19 participants according to inclusion criteria. The
participants will receive aÅ›vagandhÄ extract tablet of 1 gm, once daily
after food (hour of sleep) for 30 days, group therapy of 1 hour as 2 sittings,
once in 2 weeks and satvÄvajaya module of 4 sittings, once in a week, 1
hour each. The group therapy and satvÄvajaya module will be delivered
directly by the researcher. Assessment would be done on 0th day and 31st
day of treatment. |