| CTRI Number |
CTRI/2021/08/035396 [Registered on: 04/08/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY OF NEERKKURI (characteristics of urine) AND NEIKKURI (oil spreading pattern in urine) FOR UTHIRAVAATHASRONITHAM |
|
Scientific Title of Study
|
A STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY OF NEERKKURI AND NEIKKURI FOR UTHIRAVAATHASRONITHAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S ANANTHI |
| 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 |
8428148379 |
| Fax |
|
| Email |
drananthisubramani96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A BALAMURUGAN MDS |
| 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
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A BALAMURUGAN MDS |
| 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
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Facilities and central Library of 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-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 S ANANTHI |
Government siddha medical college and hospital |
Room no:2,Department of Noi Naadal,
Government siddha medical college and hospital,
Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
8428148379
drananthisubramani96@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: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with any of the following symptoms will be included in the study.
1.Swelling in the knee joint, ankle joint, dorsal foot of the body
2.pain in the small joints of the toes and fingers
3.Stress
4.Loss of appetite |
|
| ExclusionCriteria |
| Details |
Subject with;
Azhal keelvayu
Kalanchaga vaatham
Vazhi keelvayu
Pregnant women
Lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing siddha diagnostic methodology especially Neerkkuri and Neikkuri in Uthiravaathasronitham |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Naadi nadai and Manikkadai nool are used for the diagnosis of Uthiravaathasronitam.
Making treatment easy by framing prompt diagnosis.
To prevent complications related to the disease. |
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)
|
10/08/2021 |
| 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
|
No |
|
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 Neerkkuri and Neikkuri in patients of Uthiravaathasronitam which is one of the types of vaatha diseases mentioned in Yugi Vaithiya Sinthamani. Assessment of other diagnostic methods such as Naadi Nadai and Manikkadai Nool is also done. The subjects who satisfy the inclusion and exclusion criteria will be enrolled and the test procedures will be done and recorded as per the protocol. |