| CTRI Number |
CTRI/2020/12/030001 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on Siddha Diagnostic Methodolgy of Neerkuri and Neikuri for VATHA MAGOTHARAM |
|
Scientific Title of Study
|
ASTUDY ON SIDDHA DIAGNOSTIC METHODOLOGY OF NEERKURI AND NEIKURI FOR VATHAMAGOTHARAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Ramanujam |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Noi naadal Government siddha medical college and hospital palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9791517511 |
| Fax |
|
| Email |
drramanujam123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundarajan MDs |
| Designation |
Reader |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Noi naadal
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 Sundarajan MDs |
| Designation |
Reader |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Noi naadal
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, Tirunelveli-627002 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital palayamkottai |
| Address |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Tamilnadu |
| 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 P Ramanujam |
Government siddha Medical College and Hospital,Palayamkottai |
Noi Naadal, room no 2
Tirunelveli
TAMIL NADU |
9791517511
drramanujam123@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: K703||Alcoholic cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Anaemia
2.Emaciation
3.Loss of appetite
4.Bloatedness
5.Non-expressive face
6.Increase lower abdominal distension |
|
| ExclusionCriteria |
| Details |
1.Tuberculosis
2.Chronica diabetes mellitus
3.age below 25 years and above 70 years
4.Pitha Magotharam
5.Kaba Magotharam |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing Siddha diagnostic methodology especially Naadi, Neerkuri and Neikuri for Vatha Magotharam |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing other Siddha Diagnostic methodology such as Thegi ilakkanam and Manikadainool for vatha magothoram |
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)
|
23/12/2020 |
| 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 procedures especially NAADI, NEERKURI and NEIKURI in patients of VATHA MAGOTHARAM which one type of Magotharam(Peruvaiyuru) mentioned in YUGI MUNI VAITHIYA SINDHAMANI.
Assessment of other diagnostic methods such as Thegi Ilakkanam. Manikadinool is also done.
The subjects who satisfy the inclusion and exclusion criteria will be enrolled. The test procedure will be done and records as per the protocol. |