| CTRI Number |
CTRI/2020/12/029941 [Registered on: 21/12/2020] Trial Registered Prospectively |
| Last Modified On: |
14/02/2023 |
| 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 detect early cognitive decline |
|
Scientific Title of Study
|
A survey study to identify the risk group of Medha Hrasa(cognitive decline) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malavika B |
| Designation |
PG Scholar, Department Of Manovigyana Evum Manasa Roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9980072909 |
| Fax |
|
| Email |
malavikablk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha H P |
| Designation |
Professor, Department Of Manovigyana Evum Manasa Roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9980168208 |
| Fax |
|
| Email |
drsavithahp@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savitha H P |
| Designation |
Associate Professor, Department Of Manovigyana Evum Manasa Roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9980168208 |
| Fax |
|
| Email |
drsavithahp@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
B M Road,Thanniruhalla,Hassan, Karnataka, Hassan |
| Type of Sponsor |
Private 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 Malavika B |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
B M Road, Thanniruhalla, Hassan, 573201
Hassan
KARNATAKA |
9980072909
malavikablk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ï‚· Subjects willing to sign the informed consent form.
ï‚· Apparently physically and mentally healthy subjects.
ï‚· Subjects who are literate. |
|
| ExclusionCriteria |
| Details |
Known case of any major psychiatric illnesses.
 Known case of Parkinson’s disease, stroke or epilepsy.
ï‚· Subjects with known history of uncontrolled diabetes mellitus, hypertension or other
metabolic conditions.
ï‚· Subjects under the influence of psychoactive substance. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess early cognitive decline in middle age |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HELPS IN EARLY INTERVENTION TO PREVENT MILD COGNITIVE IMPAIRMENT AND ALZHIMERS DISEASE |
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "350"
Final Enrollment numbers achieved (India)="350" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2020 |
| Date of Study Completion (India) |
15/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/02/2022 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will be a cross-sectional study among individuals fulfilling the inclusion criteria. After screening each subject who are willing to sign the informed consent, their cognition will be assessed using SLUMS (Saint Louis University Mental Status) Exam. The SLUMS consists of 11 items, and measures aspects of cognition that include orientation, short-term memory, calculations, the naming of animals, the clock drawing test and recognition of geometric figures. Scores range from 0 to 30. In a person with a high school education, scores of 27 to 30 are considered normal, scores between 20 and 27 suggest a mild neuro-cognitive disorder, scores between 1 to 19 indicate dementia. In a person with less than high school education, scores between 20 to 30 are considered normal, scores between 14 to 19 suggest a mild neuro-cognitive disorder and scores between 1-14 indicate dementia. The data so collected will be classified, analyzed, and interpreted using suitable statistical methods. |