| CTRI Number |
CTRI/2024/06/069577 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
An observational study on siddha diagnostic methods and line of treatment for Dhoora Soolai(Dysmenorrhea) |
|
Scientific Title of Study
|
An Observational Study On Siddha Diagnostic Methodology Especially Neerkuri, Neikuri And Line Of Treatment, Nithya Ozhukam For DHOORA SOOLAI |
| 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 E BEAUTLIN SHARMY |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department Of Noi Naadal, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9600793459 |
| Fax |
|
| Email |
beautlinsharmy200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A 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 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A 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 627002
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College And Hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Goverment 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 E Beautlin Sharmy |
Government Siddha Medical College & Hospital |
Department of Noi Naadal,
Branch V
Room number 11
Tirunelveli
TAMIL NADU |
9600793459
beautlinsharmy200@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: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient having following symptoms
Scanty flow of menstrual blood
Abdominal discomfort
Lower abdominal pain
Headache
Excessive saliva secretion
Anorexia |
|
| ExclusionCriteria |
| Details |
Before puberty and after menopause
Patients with any serious systemic illness
Carcinoma |
|
|
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 Dhoora Soolai |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Naadi nadai for Dhoora soolai patients
To asssess Manikadai nool in Dhoora soolai patients |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
11/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Background This study is designed to document the neikuri patterns and other siddha diagnostic methodology for patients with DHOORA SOOLAI- Dysmenorrhea Expecting outcome Siddha diagnosis especially neerkuri and neikuri may be used to confirm Dhoora Soolai. Proper line of treatment and nithya ozhukam could be framed based on the derangements.
|