| CTRI Number |
CTRI/2023/08/056514 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
15/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study on Siddha Diagnostic tools including line of treatment and dietary regimen for Endometrial inflammation Yoni Soolai patients |
|
Scientific Title of Study
|
An observational study on Siddha Diagnostic tools including line of treatment and dietary regimen for Yoni Soolai patients attending OPD GSMC&H, Palayamkottai. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemavathi P |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical college and hospital, Palayamkottai |
| Address |
Room no 2
Department of Noi Naadal
Government Siddha Medical college and hospital,
Palayamkottai
Room no 2
Department of Noi Naadal
Government siddha medical college and hospital,palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9488880598 |
| Fax |
|
| Email |
drhemavathip92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrA BALAMURUGAN |
| 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, Tamilnadu 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.adhitya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrA BALAMURUGAN |
| 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, Tamilnadu 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.adhitya@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 |
| 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 |
| DrPHemavathi |
Government Siddha medical college and hospital, Palayamkottai |
Room no 2
Department of Noi Naadal
Government Siddha medical college and hospital, Palayamkottai
Tirunelveli
TAMIL NADU |
948880598
drhemavathip92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government Siddha medical College palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Abdominal swelling
Abnormal vaginal bleeding
Abnormal vaginal discharge
constipation
fever
A general feeling of sickness
Discomfort while having a bowel movement
Pain in the pelvis, over the abdomen and rectal area |
|
| ExclusionCriteria |
| Details |
Below 20 years and above 60 years
CA of cervix
Myoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Neerkuri & Neikuri for YONI SOOLAI patients |
8 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the Neerkuri & Neikuri for YONI SOOLAI patients |
1 year 6 months |
|
|
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)
|
25/08/2023 |
| 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
|
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 Neerkuri and Neikuri in patients of "YONI SOOLAI". Assessment of other diagnostic methods such as Naadi nadai and Manikadai nool were also done |