| CTRI Number |
CTRI/2021/04/033254 [Registered on: 29/04/2021] Trial Registered Prospectively |
| Last Modified On: |
28/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY THE ROLE OF NASAL DROPS OF TIL TAILA ON SLEEP |
|
Scientific Title of Study
|
TO STUDY THE PHYSIOLOGICAL EFFECT OF TIL TAILA NASYA ON NIDRA(SLEEP) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishakha |
| Designation |
PG Scholar |
| Affiliation |
shri krishna government ayurvedic college and hospital,kurukshetra |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital sec-8, umri road, kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9729497710 |
| Fax |
|
| Email |
vishakha16493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PC Mangal |
| Designation |
Proffessor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital sec-8, umri road, kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416159505 |
| Fax |
|
| Email |
pmangla69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishakha |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital sec-8, umri road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9729497710 |
| Fax |
|
| Email |
vishakha16493@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Dr Vishakha |
| Address |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital sec-8, umri road, Kurukshetra, 136118 |
| Type of Sponsor |
Other [self] |
|
|
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 PC Mangal |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra |
PG Department of Kriya Sharir, Shri Krishna Government Ayurvedic College and Hospital sec-8, umri road, Kurukshetra, 136118
Kurukshetra
HARYANA |
9416159505
pmangla69@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep Quality |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasya by Til Taila |
Informed written consent will be taken from the patients. Pratimarsh Nasya will be advised to them with 2-2 drops of til taila in each nostril before going to sleep for 28 days. Pathya aahar vihar will be advised to all individuals. |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals of age group between 18-60 years. |
|
| ExclusionCriteria |
| Details |
Subjects below 18 years and above 60 years.
Pregnancy
Indigestion
Fever
Alcoholic
Obese
Suffering from any severe CNS disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on Sleep Quality |
Follow up on 15 and 30th day of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Nasya on sleep |
Effect of Nasya on sleep |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
05/05/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sleep plays a very important role in physical as well as mental health. Sleep enables the body to repair and be fit for next day. Insomnia is most common sleep disorder worldwide. Insomnia can lead to many psychosomatic manifestations like fatigue, high blood pressure, lack of concentration and also effects quality of life. In Ayurveda, Nasya karma is quoted as Sukhswapna Prabhodak . Nasya is also provides nourishment and strength to nerve , veins ligaments, tendon which are related to head. Til Taila is best among all the oils having property of vata shaman and medhya. Nasya practice in daily routine at the end of the day helps individual to get a quality sleep and wake up on time. |