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CTRI Number  CTRI/2024/10/075420 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Yognidra and Gayatri Mantra in mobile phone addiction  
Scientific Title of Study   A comparative study to evaluate the efficacy of yognidra and ajpajapa gayatri mantra in subjects suffering from nomophobia 
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 Shikha Singh Taroliya 
Designation  M D SCHOLAR 
Affiliation  Post graduation institute of ayurveda 
Address  Department of swasthavritta post graduation institute of ayurveda dr sarvepalli radhakrishnan rajasthan ayurveda university Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8279291732  
Fax    
Email  shikhataroliya131096@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Dr Saurabh Agrawal 
Designation  Associate Professor PG Department Of Swasthavritta 
Affiliation  Post graduation institute of ayurveda 
Address  Department of swasthavritta post graduation institute of ayurveda dr sarvepalli radhakrishnan rajasthan ayurveda university Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9972143436  
Fax    
Email  Drsaurabh101@gmail.com  
 
Details of Contact Person
Public Query  
Name  Professor Dr Saurabh Agrawal 
Designation  Associate Professor PG Department Of Swasthavritta 
Affiliation  Post graduation institute of ayurveda 
Address  Department of swasthavritta post graduation institute of ayurveda dr sarvepalli radhakrishnan rajasthan ayurveda university Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9972143436  
Fax    
Email  Drsaurabh101@gmail.com  
 
Source of Monetary or Material Support  
Post graduation institute of ayurveda dr sarvepalli radhakrishnan rajasthan ayurveda university Jodhpur rajasthan india pin code 342037  
 
Primary Sponsor  
Name  Post graduation institute of ayurveda 
Address  Department of swasthavritta post graduation institute of ayurveda dr sarvepalli radhakrishnan rajasthan ayurveda university Jodhpur  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shikha Singh Taroliya  sanjeevani hospital dsrrau jodhpur  ROOM No 8 OPD OF DEPARTMENT OF SWASTHAVRITTA POST GRADUATION INSTITUTE OF AYURVEDA Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVEDA UNIVERSITY JODHPUR
Jodhpur
RAJASTHAN 		 08279291732

shikhataroliya131096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee post graduate institute of ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NO MOBILE PHONE PHOBIA 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoga nidra and ajapajap gayatri mantra (Procedure Reference: yoga nidra refrance swami satyanad saraswati and ajapajap gayatri mantra refrance rigveda and gherand samhita, Procedure details: yoga nidra 20 minute before sunrise ajapajap gayatri mantra 20 minute before sunrise Delete)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1 Patients aged between 16 to 24 years irrespective of their caste race and sex etc
2 Patients who has regularly used mobile phone at least 21 days
3 Addicted to social media platforms like WhatsApp Facebook Instagram snapchat etc
4 Daily Mobile uses Of 3 hours & double 
 
ExclusionCriteria 
Details  1 Patients aged below 16 and above 24 years
2 Patient who is not using mobile phone less than 21 days
3 Psychosis
4 Drug abuse
5 DID Dissociate Identy Disorder
• Diagnosed case of anxiety and depression. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease addiction of mobile phone  45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease anxiety due to decrease use of mobile phone  45 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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   An interventional study will be done on number of 60 patients with procedure of yog nidra and ajpajapa gayatri mantra for 20 minutes before sunrise for 45 days with 15 days of followup.the patients will acessed on the basis of inclusion criteria and based on subjective criteria. the data will be collected and analyzed statistically using appropiate test. 
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