| CTRI Number |
CTRI/2024/04/066563 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Siddha Investigatory Tool in urine For “VALI IYA NOI†Patients |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY ON DOCUMENTATION OF SIDDHA DIAGNOSTIC METHODOLOGY-ENVAGAI THERVU AND MANIKADAI NOOL FOR “VALI IYA NOI†PATIENTS |
| 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 K Vignesh |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and Hospital, Palayamkottai, Tirnelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778635889 |
| Fax |
|
| Email |
drvignesh97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and Hospital, Palayamkottai, Tirnelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and Hospital, Palayamkottai, Tirnelveli.
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, Palayamkottai, Tirunelveli, Tamilnadu-627002, India |
|
|
Primary Sponsor
|
| Name |
Government Siddha medical College and hospital palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai, Tirunelveli Tamilnadu-627002, India |
| 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 K Vignesh |
Government Siddha Medical College and Hospital, Palayamkottai |
Room no2, Department of Noi Naadal. Government Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU |
8778635889
drvignesh97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Government Siddha medical College and hospital palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Elevated S.Urea
Elevated S.Creatinine
Albuminuria
Glucosuria
Forthy urine
Decreased urine output
|
|
| ExclusionCriteria |
| Details |
atients undergoing Hemodialysis
Patients with partial or complete Nephrectomy
Renal carcinoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cost effective diagnosis
Non- invasive method of diagnosis
Siddha diagnosis specially Neerkuri and Neikuri may be used to confirm VALI IYA NOI .
Naadi and Manikkadai nool may be considered for the diagnosis of VALI IYA NOI
Making treatment easy by framing prompt diagnosis
|
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Manikkadai nool(Siddha thread
diagnostic tool) along with Neerkuri(Siddha Urine
analysis methodology) & Neikuri patterns
(Siddha Urine analysis pattern) in Vali iya noi
patients at a single visit. |
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)
|
02/05/2024 |
| 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
(Urine analysis in Siddha system of medicine) in patients of "Vali iya noi".
Assessment of other diagnostic methods such as Naadi Nadai (Siddha Pulse diagnostic method)
and Manikkadai Nool is also done |