| CTRI Number |
CTRI/2025/03/081838 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Effect Of Restraining Urge For Sleep On Digestive Fire |
|
Scientific Title of Study
|
An Observational Study To Evaluate The Effect Of Nidra Vegadharana On Agni |
| 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 Pooja Katekar |
| Designation |
MD Scholar |
| Affiliation |
Shri NPA Government Ayurved College, Raipur, Chattisgarh, India |
| Address |
Department of Samhita Siddhant Shri NPA Government Ayurved College, Raipur, Chattisgarh, India 492010
Speciality Clinic - 1,2
Raipur
CHHATTISGARH
492010
India |
| Phone |
7218234362 |
| Fax |
|
| Email |
pooja811sk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prema Bhagat |
| Designation |
Reader Samhita Siddhant |
| Affiliation |
Shri NPA Government Ayurved College, Raipur, Chattisgarh, India |
| Address |
Department of Samhita Siddhant Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chattisgarh India 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9977108102 |
| Fax |
|
| Email |
bhagatprema2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Singh |
| Designation |
Lecturer Samhita Siddhant |
| Affiliation |
Shri NPA Government Ayurved College, Raipur, Chattisgarh, India |
| Address |
Department of Samhita Siddhant Shri Narayan Prasad Awasthi Government Ayurved College, Raipur, Chattisgarh India 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
7999517699 |
| Fax |
|
| Email |
drshwetasingh05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Narayan Prasad Awasthi Government Ayurved College,Raipur,Chattisgarh,India. 492010 |
|
|
Primary Sponsor
|
| Name |
Principal Shri Narayan Prasad Awasthi Government Ayurved College,Raipur,Chattisgarh,India |
| Address |
Department of Samhita Evum Siddhant Shri Narayan Prasad Awasthi Government Ayurved College, Raipur Chattisgarh India
492010 |
| 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 Pooja Katekar |
Shri Narayan Prasad Awasthi Government Ayurved College and Hospital, Raipur, Chattisgarh |
Samhita OPD Speciality Clinic-1,2 of Shri Narayan Prasad Awasthi Government Ayurved College and Hospital, Raipur, Chattisgarh, India 492010
Raipur
CHHATTISGARH |
7218234362
pooja811sk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Principal Shri NPA Government Ayurveda College, Raipur, Chattisgarh India 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers restraining urge for sleep, belonging to 16 to 60 years age group |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are willing for survey study.
2.Volunteers and Patients restraining urge for sleep.
3.Subjects will be selected irresspective of their Gender, Socio-economic status, Education, Profession, Religion, etc |
|
| ExclusionCriteria |
| Details |
1.Subjects who are not willing for survey study.
2.Volunteers and Patients not restraining urge for sleep.
3.Subjects who are below 16 years and above 60 years.
4.Critically ill Patients.
5.Patients with major psychological problems.
HIV/VDRL factors/HbsAg/HCV positive cases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine relationship of Nidra Vegadharana with Agni. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To achieve social awareness about having proper Nidra. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
17/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Introduction- Ayurveda states that Aarogyam (health) is the sole path to achieve every desired Purushartha viz. Dharma, Artha, Kama and Moksha . To maintain positive health, numerous principles have been provided by Acharyas. Among which, Adharneeya Vega (natural urges in the body which should not be restrained) is one of the prime principles. Acharya Charaka has described thirteen Adharniya Vegas. Habitual or oblivious suppression of natural urges not only affects the homeostasis of Dosha, Dhatu, Mala, Agni but also mind, soul and sense organs. According to Acharya Charaka, the Agni gets vitiated by the suppression of the natural urges. Acharya Charaka has described four types of Jatharagni – Samagni, Tikshnagni, Mandagni and Vishmagni . The Bala of Dhatwagni depends upon the Bala of Jatharagni . According to Acharya Sushruta, Nidra offers us Agnidipti (proper digestion and metabolic activities) when consumed at right time. In Ayurveda, Nidra is included in ‘Trayopstambha’ . Happiness and sorrow, growth and wasting, strength and weakness, virility and impotence, knowledge and ignorance, as well as life and it’s cessation depend on Nidra. In present era, due to late night work, night shifts, odd life styles, increased screen time or any other reasons people suppress the urge for sleep which leads to Jrimbha (yawning), Angamarda (malaise), Tandra (drowsiness), Shiroroga (diseases of the head) and Akshi Gaurava (heaviness in eyes). According to contemporary science, quantity and quality of sleep affects various metabolic, endocrine and neurological functions of body. Vegadharana as Nidana is a unique concept of Ayurveda and Nidana Parivarjana is the first and foremost treatment in Ayurveda. Therefore as Vaidya, we should consider Nidra Vegadharana along with other Adharneeya Vega before concluding any diagnosis.
Need of the study-
1.India is the second most sleep deprived country after Japan. Longer work hours, shift work, greater access to television-internet and bedtime procrastination are some of the reasons behind sleep deprivation. 53.1% of young adults report engaging in bedtime procrastination and about 20% of workers are engaged in some kind of shift work which results in chronic sleep loss and disruption of circadian rhythm. 31.66% Indian youth in the 16-30 age groups are chronically sleep deprived. Men and women who sleep less than 6 hours have increased significantly over the last 20 years. These data suggest the current situation of Nidra Vegadharana.
2.Contemporary science also states that sleep deprivation alters the glucose metabolism and hormones involved in regulating metabolism i.e. decreased leptin and increased ghrelin levels. There is great need to create awareness in general population about having proper Nidra. So, a study will be done to see the effect of Nidra Vegadharana on Agni. The result whatever will be, it will help the researcher for further study.
3.It is not observed that the study of Agnidushti was carried out with Nidra Vegadharana taken into consideration as Nidana. Therefore the scholar will try to research prevalence of Nidra Vegadharana and it’s effect on Agni.
|