| CTRI Number |
CTRI/2023/10/058351 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Yoga in Anger Management among 14 to 20 year age group. |
|
Scientific Title of Study
|
A Single-Arm Clinical Trial to study the effect of Yoga Regime in Anger Management amongst Adolescent. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Pranita Gatlewar |
| Designation |
M.D. Scholar Swasthvritta |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28. |
| Address |
OPD NO.4,Department of Swasthvritta, Sane Guruji Arogya Kendra,Malvadi Hadapsar. Department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28.
Pune
MAHARASHTRA
411028
India |
| Phone |
8668709077 |
| Fax |
|
| Email |
gatlewarpranita03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Nitesh Joshi |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28. |
| Address |
OPD NO.4,Department of Swasthvritta, Sane Guruji Arogya Kendra,Malvadi Hadapsar. Department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28.
Pune
MAHARASHTRA
411028
India |
| Phone |
9890720745 |
| Fax |
|
| Email |
dr.niteshjoshi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Nitesh Joshi |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28. |
| Address |
OPD NO.4,Department of Swasthvritta, Sane Guruji Arogya Kendra,Malvadi Hadapsar. Department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28.
Pune
MAHARASHTRA
411028
India |
| Phone |
9890720745 |
| Fax |
|
| Email |
dr.niteshjoshi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthvritta and Yoga,Sane Guruji Arogya Kendra,Malvadi,Hadapsar Pune 28. |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malvadi,Hadapsar,Pune 28 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vd Pranita Gatlewar |
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune. |
OPD NO.4,Department of Swasthvritta, Sane Guruji Arogya Kendra,Malvadi Hadapsar. Department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28. MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Sane Guruji Arogya Kendra, Malvadi Hadapsar, Pune 28.
Pune
MAHARASHTRA |
8668709077
gatlewarpranita03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male subjects of age group 14-20 years with CAS score 14-63. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NA, Ritucarya: NA, Acara Rasayana:NA, Other:Subjects will attend a 30 minutes session for 5 days in a week for 6 weeks.
The Yoga module starts with an opening prayer of 2 min, followed by 4 rounds of Sooryanamaskar for 5 min, Asanas includes- Uttanasana, Paschimottanasana, Balasana,
Prasarit Padottanasana, Shavasana 1 round of each Asana for 10 min. Breathing Exercises includes Anulom Vilom Pranayama and Bhramari 3 rounds of each for 7 min. An Interactive Discussion on Yama Niyama for 4 min concluded with a closing prayer of 2 min., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Male |
| Details |
1. Age group- 14 to 20 years.
2. Only male subjects irrespective of religion, caste or race.
3. CLINICAL ANGER SCALE (CAS) score- 14 to 63. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are non-cooperative.
2. Female subjects as they will not be able to attend regular sessions during menstrual
cycle.
3. Subjects who are known cases of any systemic illness, physical disability or trauma.
4. Subjects who are on any medications, sedatives, addictions or on psychiatric treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in clinical anger scale score against an initial score. |
Pre-trial assessment on Day 0
Post-trial assessment on Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement/ Increase in Satva symptoms readings against initial readings. |
Pre-trial assessment on Day 0
Post-trial assessment on Day 30 |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2 |
|
Date of First Enrollment (India)
|
15/10/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
To study the effect of Yoga Regime in Anger Management among Adolescent.
The Clinical Anger among Adolescents of age group 14-20 years will be recorded with the help of Clinical Anger Scale and Sattva Pariksha Scale. The included subjects will be given Yoga Regime as an intervention and assessment will be recorded on 0th and 30th day. Subjects will be provided Yogasanas and Pranayama module for management of Clinical Anger. |