| CTRI Number |
CTRI/2024/09/074520 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of sleep and Dehik Prakriti |
|
Scientific Title of Study
|
A Comparative Study on Nidra in different Dehik Prakriti in view of contemporary assessment of sleep |
| 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 Bhagyesh Shrivastav |
| Designation |
MD SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Kriya Sharir, State Ayurvedic College and Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9033266010 |
| Fax |
|
| Email |
bhagyeshshrivastav91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Kriya Sharir, State Ayurvedic College and Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8299634397 |
| Fax |
|
| Email |
sureshksagar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyesh Shrivastav |
| Designation |
MD SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Kriya Sharir, State Ayurvedic College and Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9033266010 |
| Fax |
|
| Email |
bhagyeshshrivastav91@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh 226004, India |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh 226004, 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 Bhagyesh Shrivastav |
State Ayurvedic college and hospital Lucknow |
Room Number G 12, OPD no.12, PG Department of Kayachikitsa, State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh 226004, India
Lucknow
UTTAR PRADESH |
9033266010
bhagyeshshrivastav91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individual without any illness or systemic disease |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age - between 25 to 50 years.
Individual without any illness or systemic disease |
|
| ExclusionCriteria |
| Details |
Age: Below 25 years and above 50 years.
Individuals suffering from any illness like hypertension, T.B, malignancy, diabetes or systemic disease including pregnancy and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is relationship between prakriti and sleep pattern of an indiviual. |
The data will be collected once. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no relationship between prakriti and sleep pattern of an indiviual. |
The data will be collected once. |
|
|
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)
|
03/10/2024 |
| 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 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
|
100 Individuals will be selected as per the case proforma. Individuals will be observed and questioned as a part of history taking in accordance with the proforma to analyse the deha prakriti and sleep pattern of the individuals to analyse the relationship with the prakriti and nidra. |