| CTRI Number |
CTRI/2023/06/054493 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
A Descriptive Study On Siddha Diagnostic Methodology And Diet Regimen For Vatha Perumpadu (Menorrhagia) |
|
Scientific Title of Study
|
A Descriptive Study On Siddha Diagnostic Methodology Neerkuri And Neikuri , Line Of Treatment And Diet Regimen For "Vatha Perumpadu" |
| 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 Neethu P |
| Designation |
PG Scholar |
| Affiliation |
GOVT. SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI |
| Address |
Department Of Noi Nadal, Goverment Siddha Medical College And Hospital,
Palayamkottai ,
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7907488980 |
| Fax |
|
| Email |
drneethunirmal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S Sundararajan MDs |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College And Hospital Palayamkottai |
| Address |
Department Of Noi Nadal, Goverment Siddha Medical College And Hospital,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. S Sundararajan MDs |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College And Hospital Palayamkottai |
| Address |
Department Of Noi Nadal, Goverment Siddha Medical College And Hospital
Palayamkottai
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 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
| Address |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI, TIRUNELVELI , TAMILNADU -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 NEETHU P |
GOVERMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
ROOM NO 2, DEPARTMENT OF NOI NADAL , GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL , PALAYAMKOTTAI
Tirunelveli
TAMIL NADU |
7012553186
drneethunirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT SIDDHA MEDICAL COLLEGE ,PALAYAMKOTTAI, TIRUNELVELI , TAMILNADU 627002 INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N926||Irregular menstruation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NOT APPLICABLE AS THIS IS AN OBSERVATIONAL STUDY |
| Intervention |
NIL |
NOT APPLICABLE SINCE OBSERVATIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
REPRODUCTIVE AGE GROUP FEMALES ONLY, AGE BETWEEN 20 AND 50
PATIENTS HAVING THE FOLLOWING SYMPTOMS
HEAD ACHE
BACK PAIN
BLACKISH DISCOLOURATION OF SKIN
ABDOMINAL DISTENSION
RED COLOURED AND FOUL SMELLED MENSTRUAL BLOOD |
|
| ExclusionCriteria |
| Details |
AGE GROUP BELOW 20 AND 50
PATIENTS WITH SERIOUS SYSTEM ILLNESS
CARCINOMA OF CERVIX
CERVICAL DYSPLASIA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COST EFFECTIVE SIDDHA DIAGNOSIS , NEERKURI NEIKURI TO CONFIRM VATHAPERUMPADU |
1.5 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE USAGE OF MANIKADAI NOOL AND NAADINADAI FOR THE DIAGNOSIS OF VATHA PERUMPADU |
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)
|
03/07/2023 |
| 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 ASSES THE SIDDHA DIAGNOSTICS METHODS, OF NEERKURI AND NEIKURI FOR THE DIAGNOSIS OF VATHA PERUMPADU. LINE OF TREATENT AND AND DIET REGIMEN FOR VATHA PERUMAPDU TO ASSES THE SIDDHA DIAGNOSTIC TOOLS MANIKADAI NOOL AND NAADINADAI IN PATIENTS OF VATHA PERUMPADU. |