| CTRI Number |
CTRI/2024/06/069105 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
To study siddha diagnostic methodology for ceganavatham (cervical spondylosis) |
|
Scientific Title of Study
|
An Observational study on Siddha Diagnostic methodology,Line of treatment,Dietary regimen and Lifestyle modification for Ceganavatham |
| 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 C Karthick |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal , Government siddha medical college and
hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7639919395 |
| Fax |
|
| Email |
karthickc140@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Balamurugan MDS PhD |
| Designation |
Lecturer grade II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal , Government siddha medical college and
hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Balamurugan MDS PhD |
| Designation |
Lecturer grade II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal , Government siddha medical college and
hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college aand hospital,Palayamkottaai 627002 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital,Palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai 627002
Tirunelveli, Tamil Nadu. |
| 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 C Karthick |
Government siddha medical college and hospital, palayamkottai |
Room no 11, Department
of NoiNaadal,
Government siddha
medical college and
hospital, Palayamkottai,
Tirunelveli, TAMIL
NADU
Tirunelveli 627002
Tirunelveli
TAMIL NADU |
7639919395
karthickc140@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: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient who have symptoms of
Pain around the neck
Radiating pain from neck to arms
Neck stiffness
Heaviness of the body
Giddiness
Burning sensation of eyep
Patients with non communicable diseases like DM,SHT
|
|
| ExclusionCriteria |
| Details |
Age below 30 an above 65
Patients who have coronary artery disease
Tuberculosis in spine
Secondary malingnancy
Pregnancy aand lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the neikuri and neerkuri patterns( siddha diagnostic parameter) of ceganavatham patients |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe naadi nadai and manikadai nool in ceganavathaam patients
|
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2024 |
| 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="6"
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 assess the siddha diagnostic procedures especially Neerkuri and Neikuri in patients of ceganavatham and also Assessment of other diagnostic methods such as Naadi Nadai and Manikkadai Nool for ceganavatham patients |