| CTRI Number |
CTRI/2025/01/078853 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Smruti Study Assessing memory function in 30-60 year olds |
|
Scientific Title of Study
|
An observational study to assess Smruti(memory) in healthy middle age group individuals. |
| 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 Tejrao Dahake |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and research centre |
| Address |
Department of Kriya Sharir
PDEAs College of Ayurveda and research centre Nigdi
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9604236174 |
| Fax |
|
| Email |
bkapurva9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Nyahalse |
| Designation |
Assistant Professor and Guide |
| Affiliation |
PDEAs College of Ayurveda and research center |
| Address |
PDEAs College of Ayurveda and research centre Nigdi
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7709082385 |
| Fax |
|
| Email |
jiya.nyahalse11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurva Dahake |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and research center |
| Address |
PDEAs College of Ayurveda and research centre Nigdi
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9604236174 |
| Fax |
|
| Email |
bkapurva9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Rugnalaya and Sterling Multi-speciality
Hospital Sector no 27 Nigdi Pradhikaran
Pune 411044 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Apurva Tejrao Dahake |
| Address |
PDEAs College of Ayurveda and research center Sector no 27
Nigdi Pradhikaran Pune 411044 Maharashtra India
|
| Type of Sponsor |
Other [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 Apurva Dahake |
Ayurveda Rugnalaya and Sterling Multispeciality Hospital,Pune |
Sharir Kriya Department
sector no 27
nigdi pradhikaran Pune
411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
09604236174
bkapurva9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs College of Ayurved and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals between age group of 30 to 60 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:Nil, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals without hypertension, diabetes melli tus and hypo/hyper thyroid |
|
| ExclusionCriteria |
| Details |
c/o Traumatic Head injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess ‘Smruti’(memory) in healthy middle age group individuals with the help of Addenbrook’s cognitive examination (ACE) III scale. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find relation between ‘Smruti’(memory) & Prakruti in healthy middle age group individuals with the help of Addenbrook’s cognitive examination (ACE) III scale & MUHS Prakruti Evaluation Proforma. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
30/04/2025 |
| 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 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
|
Acharya Charak stated in Vayvibhajan shloka that, ‘Memory is good in middle age group individuals. The recent research says the increased intensity of memory loss in increasing ages and the incidence rate significantly and proportionally increases. So need to find out the age group in which memory declines by revalidating Charak Shloka. In this study Smruti(memory) will be assessed through Addenbrook’s cognitive examination (ACE) lll scale by researcher doing interview method with volunteers. Results of each activity are scored to give a total score out of 100. ACE lll scale content total 5 domains, Attention and orientation having /18 score, memory having /26 score, fluency having /14 score, language having /26 score, visuospatial having/16 score. Memory score more than or equal to 88 is normal memory, Memory score from 83 to 87 (inconclusive) is moderate memory, Memory score below 83 is low memory. Prakruti will be taken by Prakruti evaluation proforma. This study will help to aware community of this age group to provide preventive measures for AD. Lot of research work has been done on memory but no work has been done on memory in healthy middle age group individuals. |