| CTRI Number |
CTRI/2022/07/043809 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
28/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Elucidation of siddha diagnostic methodology ,line of treatment and diet regimen of korai vadham(Lumbar spondylosis). |
|
Scientific Title of Study
|
Elucidation Of Siddha Diagnostic Methodology,Line Of Treatment And Diet Regimen Of Korai Vadham |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Kowsalya |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of Noi Nadal , Government siddha medical college and hospital , Palayamkottai , Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9498449236 |
| Fax |
|
| Email |
kowsalya4208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MDs |
| Designation |
Reader |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of Noi Nadal , Government siddha medical college and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan MDs |
| Designation |
Reader |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of Noi Nadal , Government siddha medical college and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital Palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai, Tirunelveli |
| 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 |
| DrGKowsalya |
Government siddha medical college and hospital. |
Room no.2, Department of Noi Nadal, Government siddha medical college and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
9498449236
kowsalya4208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with symptoms of
Pain present in low back ,leg,thighs.
Restrictions of movements.
Pain worsens by standing or walking.
Pain aggravates by forward bending. |
|
| ExclusionCriteria |
| Details |
Age group below 30 and above 65.
Kudaithiri vadham.
Fracture or trauma in hip bone.
Pregnancy women, lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Neerkuri and Neikuri of korai vadham. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Naadi Nadai of korai vadham.
To assess Manikkadai Nool and documentation of korai vadham. |
1 year |
|
|
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)
|
15/07/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 procedure especially Neerkuri and Neikuri in patients of Korai vadham mentioned in Yugi Muni vaidhiya kaviyam . Assessment of other diagnostic methods such as Naadi Nadai and Manikkadai Nool is also done. The subject who satisfy the inclusion and exclusion criteria will be enrolled and the test procedures will be done and recorded as per protocol |