| CTRI Number |
CTRI/2024/05/068098 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Omkar chanting on Manas Prakriti [ personality] and Anxiety [Chittodvega] in common people . |
|
Scientific Title of Study
|
Cogitation of Manas Prakriti with special reference to Anxiety [Chittodvega] and effect of Omkar chanting on it. |
| 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 Simant Sourav |
| Designation |
HOD, Department of Kriya Sharir |
| Affiliation |
Government Ayurved College , Patna , Bihar |
| Address |
Department of Kriya Sharir , college division room no 4 1 st floor, GACH , Patna , Department of Kriya Sharir, college division room no 4 , 1 st floor ,GACH,Patna, Bihar Patna BIHAR 800003 India |
| Phone |
7060197269 |
| Fax |
|
| Email |
drsimant.sourav@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Simant Sourav |
| Designation |
HOD, Department of Kriya Sharir |
| Affiliation |
Government Ayurved College , Patna , Bihar |
| Address |
Department of Kriya Sharir ,college division room no 4 GACH , Patna , Department of Kriya Sharir, college division, room no 4 GACH,Patna, Bihar Patna BIHAR 800003 India |
| Phone |
7060197269 |
| Fax |
|
| Email |
drsimant.sourav@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Nibha Pandey |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College , Patna , Bihar |
| Address |
Department of Kriya Sharir , college division , room no 4 , 1 st floor GACH , Patna , N/A Patna BIHAR 800003 India |
| Phone |
7060197269 |
| Fax |
|
| Email |
dr.nibhasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College Kadam kuan Patna
Bihar INDIA 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved college ,Patna ,Bihar |
| Address |
Government Ayurved College , Patna , Kadam Kuan, Bihar 800001 |
| Type of Sponsor |
Government medical college |
|
|
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 Simant sourav |
Government Ayurved College & Hospital ,Patna , Bihar |
Department of Kriya Sharir 1 st floor, Government Ayurved College ,patna, Bihar 800003 Patna BIHAR |
7060197269
drsimant.sourav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Goverment Ayurved College , Patna , Bihar ,800003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chittodvega/ Anxiety |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mantra-cikitsA, मनà¥à¤¤à¥à¤°-चिकितà¥à¤¸à¤¾ | (Procedure Reference: Rigveda, Sound Medicine, OMKAR chanting, Procedure details: OM chanting ,30 minutes per day, for 3 months)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
50 individuals all female , of above age group , Indian students understanding hindi & english |
|
| ExclusionCriteria |
| Details |
all males of any age group were excluded , all females of age less than 20 yrs & more 30 yrs were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in sattvic quality & decline in rajsik & tamsik quality of mind |
30 min per day for 3 mths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in life quality |
30 min per day for 3 mths |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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) |
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
|
in present scenario during and after lockdown period of corona we have seen increased incidence of anxious mind manifestation like domestic violence, street fight etc. these are due to increased rajas and tamas quality in mind and decline in satvik quality in mind. It can be a permanent personality trait or may be due to situational agravance. Allopath has only some medicines like sedatives to calm anxious mind but they come with many health hazards. and they don’t serve as permanent remedy. On other hand Ayurveda as part of satvajay chikitsa propogate many non pharmaceuticals methods like prayer, meditation, chanting, classical dance form which help to connect to self and relieve stress. meditation and mantra chanting are some most useful remedy to relax mind thereby helping to treat anxiety. OM is one of the most simple mantra which is easy to pronounce for anyone and has inumerable health benefit as it is BEEJ MANTRA and also known as pranav sound. so in present scenario where mental ailments are soaring up Mantra meditation with healthy life style is ultimate solution with minimum risk and side effects plus maximum benefit and easy on pocket. |