| CTRI Number |
CTRI/2025/07/091247 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Survey study to find out how common Nidra Viparyay (Sleep irregularities) are and how they affect their health |
|
Scientific Title of Study
|
Prevalence of NIDRA VIPARYAY (i.e.RATRIJAGRAN & DIWASWAPNA- SLEEP IRREGULARITIES) & its impact on the health- A Survey Study. |
| 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 Apurva D Maru |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurveda College and Hospital |
| Address |
OPD No.03, Department of Samhita and Siddhanta, Government Akhandanand Ayurveda College and Hospital, Bhadra, Ahmedabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9427346460 |
| Fax |
|
| Email |
apurvamaru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokesh Chandra Sharma |
| Designation |
HOD Samhita & Siddhant |
| Affiliation |
Government Akhandanand Ayurveda College and Hospital |
| Address |
OPD No.03, Department of Samhita and Siddhanta, Government Akhandanand Ayurveda College and Hospital, Bhadra, Ahmedabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9045188509 |
| Fax |
|
| Email |
drlokesh70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lokesh Chandra Sharma |
| Designation |
HOD Samhita & Siddhant |
| Affiliation |
Government Akhandanand Ayurveda College and Hospital |
| Address |
OPD No.03, Department of Samhita and Siddhanta, Government Akhandanand Ayurveda College and Hospital, Bhadra, Ahmedabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9045188509 |
| Fax |
|
| Email |
drlokesh70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda College and Hospital, Bhadra, Ahmedabad, Gujarat 380001, India. |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College and Hospital |
| Address |
OPD No.03, Department of Samhita and Siddhanta, Government Akhandanand Ayurveda College and Hospital, Bhadra, Ahmedabad. |
| 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 Apurva D Maru |
Government Akhandanand Ayurveda College and Hospital |
OPD No.03, Department of Samhita and Siddhanta, Government Akhandanand Ayurveda College, Ahmedabad.
Ahmadabad
GUJARAT |
9427346460
apurvamaru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-Government Akhandanand Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals who:Self-report no major illnesses.Are not taking medications for chronic diseases (unless otherwise stated).Are functionally normal in daily activities. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Asking survey questions regarding daily routine, Ritucarya: Asking survey questions regarding night sleep routine, Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between 18 to 45 years of age group
Night shift workers more than 6months of work, Students etc
Individuals will be selected irrespective of any caste, gender, religion etc
Individuals who are willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Individuals who have pathological conditions of Nidra like Insomnia (Nidra Nash) will be excluded.
Individuals who suffer from any systemic diseases or takes long term medicines will be excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| After collecting all the survey data of all 100 sample size the results, discussion and conclusion will be checked based on certain criteria related to nidra Viparyay and its impact on health in stipulated time period of thesis. |
Individuals survey study will be done withing next 7-8 months with the help of survey questions than After collecting all the survey data of all 100 sample size the results and calculation will be checked based on certain criteria related to sleep irregularities and its impact on health in stipulated time period of thesis approx within 1.5 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/08/2025 |
| 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="5"
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
|
PREVALENCE OF NIDRA VIPARYAY (I.E. RATRI JAGRAN & DIWASWAPNA SLEEP IRREGULARITIES) & IT’S IMPACT ON THE HEALTH - A SURVEY STUDY
Need of study
As Nidra Viparyay exists as a habit within the current lifestyle, create awareness for the disadvantages it causes. Also giving it proper place and importance in the daily routine again is a very important need of the present time. Evaluation of Nidra Viparyay involves assessing an individual’s sleep patterns, considering their health, lifestyle factors, and mental state. Ayurvedic interventions for Nidra Viparyay may include awareness regarding the issue, and lifestyle modifications that will help people to improve their daily routine, avoid the disadvantages of irregular sleep.
Aim:
Study the prevalence of Nidra Viparyay & its impact on the health status.
Objectives
1. To understand the concept of Nidra viparyay from Ayurvedic literature & self-reported questionnaires for assessing Nidra viparyay from available references of various Ayurvedic texts. 2.To survey for prevalence of Nidra Viparyay & its impact on the health of individuals.
Study design: Survey study
Type of Trial: Observational
Purpose: To study the prevalence of Nidra Viparyay & its impact on health
Timing: Retrospective
Sample size: 100
DISCUSSION AND CONCLUSION
After getting all the data, discussion and conclusion will be done as per the observation and results
Declaration- The study will be completed in the stipulated time limit.
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