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CTRI Number  CTRI/2021/05/033753 [Registered on: 24/05/2021] Trial Registered Prospectively
Last Modified On: 02/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on insomnia  
Scientific Title of Study   A randomized comparative clinical study to evaluate the efficacy of yoga module and nasya karma in insomnia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanika Verma 
Designation  PhD Research Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Division of Yog and Life Science. Neuroscience Department. Anveshna Labratory. SVYASA Yoga University, Bangalore, Karnataka

Bangalore
KARNATAKA
560099
India 
Phone  9953987907  
Fax    
Email  kanika5.86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepeshwar Singh 
Designation  Associate Professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Division of Yoga and Life Science Neuroscience Department Anveshna Laboratory SVYASA Yoga University, Bangalore, Karnataka

Bangalore
KARNATAKA
560099
India 
Phone  9036367402  
Fax    
Email  deepeshwar.singh@svyasa.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kanika Verma 
Designation  PhD Research Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Division of Yoga and Life Science Neuroscience Department Anveshna Laboratory SVYASA Yoga University, Bangalore, Karnataka

Bangalore
KARNATAKA
560099
India 
Phone  9953987907  
Fax    
Email  kanika5.86@gmail.com  
 
Source of Monetary or Material Support  
Institutional funding - SVYASA University, Bengaluru 
 
Primary Sponsor  
Name  Nil 
Address  Not Applicable 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kanika Verma  SVYASA Yoga University  Division of Yoga and Life Science Neuroscience Department Anveshna Laboratory SVYASA Yoga University, Bangalore, Karnataka
Bangalore
KARNATAKA 
9953987907

kanika5.86@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  People with insomnia 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Passive control 
Intervention  Yoga and Nasya karma  Validated Yoga Module will be used for 5 days a week and the intervention will be of 48 days. Nasya Karma with Brahmi oil will be done through nasal route. 2 drops in each nostril for 48 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patient fulfilling DSM-V criteria for insomnia. 2. Patient willing to complete our treatment schedule. 3. Patient physically fit for Yoga Module. 4. Patient fit for Nasya procedure. 
 
ExclusionCriteria 
Details  1. Patient having allergy with oil application especially through nasal route.
2. Patient suffering from any severe respiratory ailments (URTI, allergic rhinitis, sinusitis, asthma).
3. Patient having any severe psychiatric disorder (schizophrenia, mania, bipolar disorders OCD).
4. Patient suffering from chronic illness (diabetes mellitus, hypertension etc.)
5. Patient taking medications like alpha-blockers, beta-blockers, corticosteroids, ace inhibitors, and statins.
6. Drug withdrawal syndromes (barbiturates, tranquillizers).
7. Substance abuse like alcohol ingestion and withdrawal.
8. Endocrine or metabolic disorders (hypothyroidism or hyperthyroidism).
9. Pregnant & lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sleep Quality  Two time points
Day 1
Day 48 
 
Secondary Outcome  
Outcome  TimePoints 
1. Salivary Cortisol Test.
2. Perceived Stress Scale. (PSS)
3. Cognitive Failures Test.
4. WHO Quality of Life Scale – Brief (WHOQOL-Brief)
 
Two time points
Day 1
Day 48 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/06/2021 
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)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

In Modern medicine sedative and tranquilizer drugs are used to induce sleep in insomnia patients but later in time they lead to dependence (Tripathi, 2018). Administration of insomnia, so far, isn’t up to the mark since solutions accessible for sleep deprivation are sleep inducing instead of treating the fundamental cause. Benzodiazepines are strong sleep actuating agents commonly utilized for insomnia has a few unfavorable drug impacts such as drug dependence, temperament disorders, and GIT disorders and in some cases depression. Numerous non- pharmacological cures such as cognitive behavioral therapy are moreover utilized to overcome the adverse drug impacts of insomnia but shockingly incidences are expanding day by day (Pagel, Parnes, 2001)

In such a scenario there is need for the efficient management of insomnia in a natural way.

The reported capacity of yoga to diminish arousal recommends that it may well be an effective insomnia treatment. This recommendation is strengthened if the dispute that yoga techniques can be utilized as custom-made medications for particular disorders is genuine (Anand, 1991). Ayurveda treats Anidrä by both abhyantar and bähya cikitsä. Hence this study was selected, not only to make an impact that holistic approach of Yoga and Ayurveda both can not only cure insomnia but also can alleviate the stress which has become the new normal in today’s era. Also, by curing insomnia and reducing stress levels with the alternative therapy, it will make a huge difference in the quality of life.

 
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