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
|
|
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. |