| CTRI Number |
CTRI/2025/02/081139 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Meditation on sleep based on different body type for personalized and preventive medicine |
|
Scientific Title of Study
|
An analytical study To assess the physiological effect of meditational on Nidra w.s.r Dehik Prakriti |
| 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 Punita Sharma |
| Designation |
Ph.D Scholar |
| Affiliation |
IAS and R, Shri Krishna AYUSH Uni. Kurukshetra |
| Address |
Kriya Sharir Department, Institute for Ayurved Studies and research, SKAU, Kurukshetra
Fatehabad
HARYANA
136118
India |
| Phone |
8708765012 |
| Fax |
|
| Email |
punitadadhich93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punita Sharma |
| Designation |
Ph.D Scholar |
| Affiliation |
IAS and R, Shri Krishna AYUSH Uni. Kurukshetra |
| Address |
Kriya Sharir Department, Institute for Ayurved Studies and research, SKAU, Kurukshetra
Fatehabad
HARYANA
136118
India |
| Phone |
8708765012 |
| Fax |
|
| Email |
punitadadhich93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punita Sharma |
| Designation |
Ph.D Scholar |
| Affiliation |
IAS and R, Shri Krishna AYUSH Uni. Kurukshetra |
| Address |
Kriya Sharir Department, Institute for Ayurved Studies and research, SKAU, Kurukshetra
Fatehabad
HARYANA
136118
India |
| Phone |
8708765012 |
| Fax |
|
| Email |
punitadadhich93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra, haryana, Pin Code 136118, India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra |
| Address |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra, Haryana, Pin code 136118, India |
| Type of Sponsor |
Government medical college |
|
|
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 Punita Sharma |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra
Kurukshetra
HARYANA |
8708765012
punitadadhich93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH University, Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Both male & female individuals.
Age between 18 to 30 years.
Apparently healthy individuals are included.
who are willing to participate |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
1. Both male & female individuals.
2. Age between 18 to 30 years.
3. Apparently healthy individuals are included.
4. who are willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Subject below 18 years & above 30 years of age will be excluded.
2. Just after bath/ waking up/ food intake/ oil massage/ sunbath/ exercise/ chronic illness./
3. One who is hungry/ thirsty/ asleep.
4. Subject who already practice Mantra Chanting
5. Hospitalized Patients on Life Supports.
6. History of Cardiovascular disorder.
7. Subject with Psychic diseases
8. History of Major surgery in the recent past.
9 History of Drug intake. (Corticosteroids/ sleep medications etc.)
10. History of Alcohol & Smoking Patients.
11. Pregnant women will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study can establish the powerful impact of Meditation on Dehik Prakriti especially on Nidra. Imbalance in Various important Physiological Parameters can be treated or balanced with Meditation. According to Prakriti of Person apersonalized recommendations can be given. |
one month Trial
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will introduce physiological impact of Meditation on blood pressure and heart rate in different Prakriti. |
One Month Trial |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/03/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- Randomly selected Subjects will be analyzed by using validated Prakriti Assessment Scale prepared by CCRAS. Subjects will be divided into three Groups on the basis of predominance of three Dosha i.e Vata, Pitta & Kapha. Each group is having 25 subjects.
- Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality and quantity of Nidra in three groups.
- Other physiological parameter i.e blood pressure and heart rate will also be assessed.
- Meditation (Mantra Based) practice, Gayatri mantra chanting 108 times for 30 days daily [35] will be done.
- After 30 days Nidra and other physiological parameters will be assessed again.
- Data will be collected and Analyzed with Proper Tests.
|