| CTRI Number |
CTRI/2025/06/089619 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A study on Siddha diagnostic tools for Alzheimers disease |
|
Scientific Title of Study
|
DOCUMENTATION OF SIDDHA DIAGNOSTIC PARAMETERS FOR ALZHEIMERS DISEASE WITH SPECIAL MENTION TO PANCHAPATCHI SASTRAM AND LINE OF TREATMENT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thangagomathi K |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college, Palayamkottai |
| Address |
Room no 11
Department of Noi Nadal Government siddha medical college
Palayamkottai
Tirunelveli
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566943441 |
| Fax |
|
| Email |
thangagomathi16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college, Palayamkottai |
| Address |
Room no 11
Department of Noi Nadal Government siddha medical college
Palayamkottai
Tirunelveli
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
94434 23937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thangagomathi K |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college, Palayamkottai |
| Address |
Room no 11
Department of Noi Nadal Government siddha medical college
Palayamkottai
Tirunelveli
India
TAMIL NADU
627002
India |
| Phone |
9566943441 |
| Fax |
|
| Email |
thangagomathi16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and Hospital
Palayamkottai Tirunelveli
627002
INDIA |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and Hospital Palayamkottai Tirunelveli |
| Address |
Government siddha medical college and Hospital Palayamkottai Tirunelveli 627002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Thangagomathi K |
Government siddha medical College and hospital Palayamkottai Tirunelveli |
Room no 11
Department of Noi Naadal
Government siddha medical College and hospital Palayamkottai Tirunelveli
627002
INDIA
Tirunelveli
TAMIL NADU |
9566943441
thangagomathi16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G309||Alzheimers disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with symptoms of
Loss of memory
Difficulty in skilled movements
Communication disability
Mood swing
Inability to recognise and use familiar objects
Loss of vision and coordination |
|
| ExclusionCriteria |
| Details |
People aged below 50 years
People diagnosed with other psychiatric disorder
Patients who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document siddha diagnostic tools Naadi Neikuri and Manikadai nool for Alzheimers disease |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Panchapatchi sastram for Alzheimers disease
To propose a proper line of treatment for improving the quality of life |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/07/2025 |
| 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="2"
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
|
This study is designed to document siddha diagnostic tools Naadi Neikuri and Manikadai nool along with Panchapatchi sastram for Alzheimers disease along with line of treatment for better quality of life |