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CTRI Number  CTRI/2020/03/024390 [Registered on: 31/03/2020] Trial Registered Prospectively
Last Modified On: 13/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Distrubed Quality Of Sleep Due To Use Of Electronic Devices During Sleeping Time An Observational study  
Scientific Title of Study   An Observational Study To Assess Nidra Vaishamya Due To Use Of Electronic Devices During Nidrakal  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rameshwar Vishvakarma 
Designation  PG Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Room no 103 Department of Samhita Siddhant Parul Institute Of Ayurved Parul University P O Limda Ta Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8889540525  
Fax  02668-260201  
Email  drram525@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Vitthal Bhagat 
Designation  Associate Professor  
Affiliation  Parul Institute Of Ayurved 
Address  Room no 103 Department of Samhita Siddhant Parul Institute Of Ayurved Parul University P O Limda Ta Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9405377592  
Fax  02668-260201  
Email  drsbvijay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijay Vitthal Bhagat 
Designation  Associate Professor  
Affiliation  Parul Institute Of Ayurved 
Address  Room no 103 Department of Samhita Siddhant Parul Institute Of Ayurved Parul University P O Limda Ta Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9405377592  
Fax  02668-260201  
Email  drsbvijay@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute Of Ayurved, Parul University,PO Limda, Waghodia,Vadodara, Gujarat 391760 
 
Primary Sponsor  
Name  Parul Institue Of Ayurved 
Address  Room no 103 Department of Samhita Siddhant Parul Institute Of Ayurved Parul University P O Limda Ta Waghodia Dist Vadodara 391760 Gujarat  
Type of Sponsor  Private 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 Rameshwar Vishvakarma   Parul Institute of Ayurved and Parul Ayurved Hospital  Room no 103 Department of Samhita Siddhant Parul Institute Of Ayurved Parul University P O Limda Ta Waghodia Vadodara
Vadodara
GUJARAT 
8889540525
02668-260201
drram525@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Use of electronic devises more than one hour before going to bed
Sleeping time less than 6 hour as mentioned in Sleep Foundation Organization
 
 
ExclusionCriteria 
Details  Persons have any type of illness or any type medication
Having the age below 18 years and above 40 years
Known patients of insomnia
Sleep disorder
Person having shift duties or night shift duty
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Awareness for Electronic devices affects Nidra Kal.   1 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="290"
Sample Size from India="290" 
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)   01/04/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be done after completion of trail 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION:-

Aahara (food), Nidra (sleep) and Brahmacharyaare described to be the Trayopstambha (sub pillars) in Charak Samhita Sutrasthan“TisraishaniyaAdhyaya”. Nidra is the second most important sub pillars of life as it provide the qualities like Bala, Varna, Upachaya etc. Nidra is one of the essential factors to lead a healthy life.

यदा तु मनसि क्लान्ते कर्मात्मानः क्लमान्विताः।विषयेभ्यो निवर्तन्ते तदा स्वपिति मानवः।। (च. सू. 21/35)

Nidra is a physiological state of rest for the body, mind, sense and motor organs. When the mind is exhausted and exhausted Indriyas (sense organs) withdrawn from their object, man sleeps. 

Anidra, which means less sleep or no sleep. Ayurveda Vishwakosha describes AnidraasNidranasha.

Acharya Charak describe Nidranasha Hetu in Charak Sutrasthan

एत एव च विज्ञेया निद्रानाशस्य हेतवः । कार्य कालो विकारश्च प्रकृतिर्वायुरेव च ।। ( च. सू. 21/57)

Karya, Kaal, Vikara and Prakruti are the Hetu’s mentioned for Nidranasha. Inadequate sleep leads to increased Vata Dosha.  As mentioned in “Ayurvedadipika” Commentary by Chakrapanidatta

कार्यमिति कर्यसक्तो न निद्रां याति ।काल इति वार्धक्यं, वृद्धा हि स्वभावत एव जागरुक भवन्ति ।विकारः व्याधिः शूलादिः । प्रकृतिः स्वभावः, स्वभादेव केचिदनिद्रा भवन्ति ।विकारग्रहणेनैव वाते लब्धे पुनर्वातग्रहणं विशेषेण वायोनिद्रापहारक त्वप्रतिपादनर्थम् ।।

                                                                                                                                (च.सू.21/55-57 ) 

Now a day due to changing lifestyle and excessive using of electronic devices like Mobiles, Internet, Computer/Laptops Television etc.Disturbed the quality of sleep, which may lead to various diseases.  People spend increasingly more time on electronic devices which effect Nidra.

In modern era our Mobiles, Computer/Laptop, Television and other electronic devices have become a huge part of our daily lives that it’s often hard to put them down- even at the bedtime. People surfing the web, playing video games, watching movies or using phones for their study works which results in long night wakefulness which disturbs the quality of sleep.

 NEED OF STUDY:-

Nidra plays an important role for good and healthy life. Due to proper and adequate sleep body tissues and Dosha remain in a balanced state.

निद्रायत्तं सुखं दुःखं पुष्टिः कार्श्यं बलाबलम् । वृषता क्लीबता ज्ञानमज्ञानं जीवितं न च ।।

                                                                                                                             (च. सू. 21/36)

Acharya Charak mentioned in Charak Samhita Sutrastan Ashtauninditiya Adhayaya that a proper sleep is the source of happiness and sorrow, growth and thinness, strength and weakness, virility and sterility, knowledge and ignorance and life and death.

         Increasing use of electronic devices among people results in reduced quality of sleep. Researches shows that improper sleep increases the risk of many lifestyle disorders. The purpose of this study is to highlightin modern era how electronic devices affect healthy sleep in people. Along with changes in attitude, sudden depression, loss of self-esteem and problems in paying attention to work or study.

These days using of Smartphone’s or Laptop/Computer before bed for sleep are very common. Due to this they involve in their work in their sleeping time which effect quality of sleep

 
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