| CTRI Number |
CTRI/2025/06/088742 [Registered on: 12/06/2025] 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 of siddha diagnostic tools for urinary tract infection |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY NEERKURI NEIKKURI PANCHA PATCHI SASTHIRAM IN MOOTHIRAAVARANA VATHAM |
| 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 Tirunelveli |
| Address |
Department of Noi Nadal
Government Siddha medical College
Palayamkottai
Tirunelveli
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566943441 |
| Fax |
|
| Email |
thangagomathi16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmiya V |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college Palayamkottai Tirunelveli |
| Address |
Department of Noi Nadal
Government Siddha medical College
Palayamkottai
Tirunelveli
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566610982 |
| Fax |
|
| Email |
v.sowmiya012000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thangagomathi K |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college Palayamkottai Tirunelveli |
| Address |
Department of Noi Nadal
Government Siddha medical College
Palayamkottai
Tirunelveli
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566943441 |
| Fax |
|
| Email |
thangagomathi16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical College and hospital Palayamkottai 627002 Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and Hospital Palayamkottai Tirunelveli |
| Address |
Government siddha medical College and college Palayamkottai Tirunelveli
627002
INDIA |
| Type of Sponsor |
Government 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 Sowmiya V |
Government siddha medical College and hospital Palayamkottai Tirunelveli |
Room no 11
Department of Noi Nadal
Government siddha medical
College and Hospital Palayamkottai Tirunelveli
627002
INDIA
Tirunelveli
TAMIL NADU |
9566610982
v.sowmiya012000@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: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting symptoms of
Body pain
Burning micturition
Dysuria
Oliguria
Abdominal discomfort
|
|
| ExclusionCriteria |
| Details |
Age group below 18 years and above 70 years
Patient who are not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Neerkuri Neikkuri for MOOTHIRAAVARANA VATHAM |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Naadi Manikkadai nool measurement for MOOTHIRAAVARANA VATHAM
To assess the Pancha patchi sasthiram for MOOTHIRAAVARANA VATHAM
|
2 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)
|
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 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
Modification(s)
|
This study is designed to document siddha diagnostic procedures Naadi Neikuri and Manikadai nool along with Panchapatchi sastram for moothiraavarana vatham (Urinary tract infection) to prevent the complication related to the disease |