| CTRI Number |
CTRI/2022/09/045426 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
30/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
How meditation practices and kapalbhati affect behavior problems? |
|
Scientific Title of Study
|
Evaluation of Impact of Meditation Practices And Kapalbhati on Behavior Problems |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Thakur |
| Designation |
AYURVEDIC MEDICAL OFFICER |
| Affiliation |
Himachal pradesh university |
| Address |
Room no 411 Department of Swasthavritta Anatomy Block RGGPG Ayurvedic College And Hospital Paprola
Room no 411 Department of Swasthavritta Anatomy Block RGGPG Ayurvedic College And Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418409090 |
| Fax |
|
| Email |
drshaliniguleria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajika Gupta |
| Designation |
HOD of Swasthavritta department |
| Affiliation |
Himachal pradesh university |
| Address |
Room no 411 Department of Swasthavritta Anatomy Block RGGPG Ayurvedic College And Hospital Paprola
Room no 411 Department of Swasthavritta Anatomy Block RGGPG Ayurvedic College And Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805880245 |
| Fax |
|
| Email |
rajikadr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajika Gupta |
| Designation |
HOD of Swasthavritta department |
| Affiliation |
Himachal pradesh university |
| Address |
Room no 411 Department of Swasthavritta Anatomy Block RGGPG Ayurvedic College And Hospital Paprola
Room no 411 Department of Swasthavritta Anatomy Block RGGPG Ayurvedic College And Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805880245 |
| Fax |
|
| Email |
rajikadr@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| RGGPG AYURVEDIC COLLEGE & HOSPITAL PAPROLA |
|
|
Primary Sponsor
|
| Name |
RGGPG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA |
| Address |
RGGPG AYURVEDIC COLLEGE And HOSPITAL PAPROLA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD of Swasthavritta department |
Room no 411 department of swasthavritta anatomy block rggpg ayurvedic College and hospital paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalini Thakur |
RGGPG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA |
Room No. 409, Anatomy Block, RGGPG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
9418409090
drshaliniguleria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEChumanRGGPGayurvediccollegepaprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Meditation to be done twice a day, Ritucarya: Meditation can be done in all ritu, Acara Rasayana:For mansik shudhhi, Other:None, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers willing for trial and able to perform practices. age group 18 to 59 years irrespective of sex, age, race, religion and socioeconomic status |
|
| ExclusionCriteria |
| Details |
Volunteers not willing for trial
Volunteers below 18 and above 59 years
Volunteers having history of any serious pathologies
Pregnant and Lactating mothers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Behavior of patients such as irritability, social relations, violent behaviour, ability to solve general life problems etc. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Assessment on the basis of Behavior Scale |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/09/2022 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Each individual will practice the given meditation technique as follows- Meditation on breath with feeling of joy Duration and Schedule of meditation per day- 30 minutes twice a day morning and bed time Kapalbhati Kriya- 30 strokes at morning before meditation and 30 strokes at evening on empty stomach |