| CTRI Number |
CTRI/2024/05/067207 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
To observe the neikuri patterns in Irritable bowel syndrome patients |
|
Scientific Title of Study
|
An observational study on documentation of Siddha diagnostic methods and exploration of the disease “MIRUTHU VATHAMâ€. |
| 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 MS Barakathum najiya |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical college and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha medical College and
hospital, palayamkottai
Tirunelveli
TAMIL NADU
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9488312133 |
| Fax |
|
| Email |
drnajiyaa.bsms@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
TAMIL NADU
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
TAMIL NADU
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 Tirunelveli 627002 |
|
|
Primary Sponsor
|
| Name |
Government Siddha medical College and hospital palayamkottai |
| Address |
Department of Noi Naadal Government Siddha medical College and
hospital palayamkottai Tirunelveli 627002 |
| Type of Sponsor |
Government medical college |
|
|
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 MS Barakathum najiya |
Government 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
Tirunelveli
TAMIL NADU |
9488312133
drnajiyaa.bsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Government Siddha medical College and hospital palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Any abdominal discomfort
Experiencing an urgent need to move to your bowel
Constipation
Diarrhoea
Sometimes both constipation & diarrhoea
Pain & cramps in lower abdomen
Flatulence
Fatigue
Depression, anxiety, fear
|
|
| ExclusionCriteria |
| Details |
Celiac disease
Ulcerative colitis
Crohn’s disease
Carcinoma of colon
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Siddha diagnosis specially Senneer, Neerkuri &
Neikuri may be used to confirm
“Miruthu vatham" |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Manikkadai nool(Siddha thread
diagnostic tool) along with Neerkuri(Siddha Urine
analysis methodology) & Neikuri patterns
(Siddha Urine analysis pattern) in Miruthu vatham
patients at a single visit. |
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)
|
31/05/2024 |
| 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 Yet Recruiting |
| 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 assess the siddha diagnostic procedures especially Neerkuri and Neikuri
(Urine analysis in Siddha system of medicine) in patients of "Miruthu vatham".
Assessment of other diagnostic methods such as Naadi Nadai (Siddha Pulse diagnostic method)
and Manikkadai Nool is also done. |