| CTRI Number |
CTRI/2022/06/043251 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
10/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY , LINE OF TREATMENT AND DIET REGIMEN FOR NEERPEENISAM |
|
Scientific Title of Study
|
A STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY ,LINE OF TREATMENT AND DIET REGIMEN FOR NEERPEENISAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARYA A V |
| Designation |
PG Scholar |
| Affiliation |
GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI |
| Address |
ROOM No 2 , DEPARTMENT OF NOI NAADAL ,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI ,TIRUNELVELI
ROOM No 2,DEPARTMENT OF NOI NAADAL,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI,TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9846985714 |
| Fax |
|
| Email |
aryaav33221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A BALAMURUGAN MDs PhD |
| Designation |
LECTURER GRADE II |
| Affiliation |
GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI |
| Address |
ROOM No 2 , DEPARTMENT OF NOI NAADAL ,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI , TIRUNELVELI
ROOM No 2 ,DEPARTMENT OF NOI NAADAL,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI,TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A BALAMURUGAN MDs PhD |
| Designation |
LECTURER GRADE II |
| Affiliation |
GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI |
| Address |
ROOM No 2 , DEPARTMENT OF NOI NAADAL ,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI , TIRUNELVELI
ROOM No 2,DEPARTMENT OF NOI NAADAL ,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI,TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
| Address |
ROOM No 2,DEPARTMENT OF NOI NAADAL,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 |
| ARYA A V |
GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI |
ROOM No 2 , DEPARTMENT OF NOI NAADAL ,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI , TIRUNELVELI 627002
Tirunelveli
TAMIL NADU |
9846985714
aryaav33221@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: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL
|
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT PRESENTING SYMPTOMS OF SNEEZING , COUGH , RUNNING NOSE , PAIN PRESENT IN HEAD AND NAPE AND INCREASED PHLEGM |
|
| ExclusionCriteria |
| Details |
AGE GROUP BELOW 18 YEARS AND ABOVE 60 YEARS
PATIENT HAVING SEEZH PEENISAM , SIRAI PEENISAM , KURUTHI PEENISAM
PREGNANT AND LACTATING WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY NEERKURI AND NEIKURI FOR NEERPEENISAM |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO STUDY NAADI NADAI FOR NEER PEENISAM
TO ASSESS MANIKADAI NOOL AND ITS DOCUMENTATION |
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)
|
15/06/2022 |
| 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 PROCEDURES ESPESCIALLY NEERKURI AND NEIKURI IN PATIENTS OF NEERPEENISAM MENTIONED IN YUGU MUNI VAITHIYA KAVIYAM. ASSESSMENT OF OTHER DIAGNOSTIC METHODS SUCH AS NAADI NADAI AND MANIKADAI NOOL WILL BE DONE. SUBJECT WHO SATISFY THE INCLUSION AND EXCLUSION CRITERIA WILL BE ENROLLED AND THE TEST PROCEDURRS WILL BE DONE AND RECORDED AS PER THE TEST |