| CTRI Number |
CTRI/2019/06/019633 [Registered on: 12/06/2019] Trial Registered Prospectively |
| Last Modified On: |
02/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of urine samples for the disease Ratha soorai vaayvu |
|
Scientific Title of Study
|
A Study on siddha diagnostic methods specially Neerkuri and Neikuri for Raththa Soorai Vaayvu |
| Trial Acronym |
RSV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Balarasheeda |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
15/2 South Mutharamman kovil street South Bazaar Palayamkottai
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9655287028 |
| Fax |
|
| Email |
rasheebsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Victoria |
| Designation |
Head of the department |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
Department of Noi Naadal
palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drvictoriathangaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Victoria |
| Designation |
Head of the department |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
Department of Noi Naadal
palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drvictoriathangaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai-627002, Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai-627002, 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 |
| Dr B Balarasheeda |
Govt. Siddha Medical College |
Palayamkottai-627002, Tirunelveli
Tirunelveli
TAMIL NADU |
9655287028
rasheebsms@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: R398||Other symptoms and signs involvingthe genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Group 1
1 Age between 18 and 45
2 Both Married and Unmarried Women
3 Lower abdominal pain
4 Excessive bleeding during menstruation
Group 2
1 Pain in hip
2 Pain in thigh
3 Excessive bleeding episodes with alternative episodes of amenorrhoea
4 Miscarriage
Patients presenting with symptoms of Group 1 and any of 2-3 symptoms of group will be included in the study |
|
| ExclusionCriteria |
| Details |
1 Karparogam
2 Sronithavaayvu
3 Karpasoolai
4 Vulnerable group
5 Any other systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishing the relevance of sage Yugi symptomatology about the disease Raththa Soorai Vaayvu in present day patients sample and relevance in diagnosing the same by siddha diagnostic method neerkuri and neikuri |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Arriving at an interpretation of Raththa Soorai Vaayvu with the findings of
1 thega ilakanam
2 mukkutram
3 envagaithervu
4 panchapathchi |
1 year |
|
|
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)
|
12/06/2019 |
| Date of Study Completion (India) |
09/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to siddha concept ,the term disease defined as alteration in uyir thathukal and udal thathukal. RATHTHA SOORAI VAAYVU is one of the disease mentioned in YUGI MUNI VAITHIYA KAAVIYAM..It is characterised by lower abdominal pain,excessive bleeding during menstruation,pain in hip and thigh region,excessive bleeding episodes with alternative episodes of amennorhea and miscarriage.
|