| CTRI Number |
CTRI/2023/07/055630 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| 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 symptomatology of Azhal Kalladaipu (Renal Calculi) |
|
Scientific Title of Study
|
A Descriptive study on Siddha diagnostic methodology and symptomatology of Azhal Kalladaipu (Renal Calculi) |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Pavithra |
| Designation |
PG Scholar |
| Affiliation |
PG Scholar |
| Address |
Department of Noi Naadal,
Government Siddha medical College and hospital, palayamkottai
Department of Noi Naadal, Government Siddha medical college and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8838090280 |
| Fax |
|
| Email |
pavisakthibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Balamurugan |
| Designation |
Lecturer grade-II |
| Affiliation |
Lecturer grade-II |
| Address |
Department of Noi Naadal,
Government Siddha medical College and hospital, palayamkottai
Department of Noi Naadal,
Government Siddha medical college and hospital,
Palayamkottai.
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 |
Lecturer grade-II |
| Address |
Department of Noi Naadal,
Government Siddha medical College and hospital palayamkottai
Department of Noi Naadal,
Government Siddha medical college and hospital,
Palayamkottai.
Tirunelveli
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 |
Other [Government Siddha medical College and hospital palayamkottai ] |
|
|
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 S Pavithra |
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 |
8838090280
pavisakthibsms@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: N219||Calculus of lower urinary tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS PRESENTING SYMPTOMS OF
OLIGURIA
DYSURIA AND BURNING SENSATION
PAIN IN THE URETHRA
NAUSEA AND VOMITING
HAEMATURIA |
|
| ExclusionCriteria |
| Details |
CHOLECYSTITIS
KIDNEY DISEASE
ECTOPIC PREGNANCY
APPENDICITIS
HEPATITIS
URINARY TRACT INFECTION |
|
|
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
“Azhal kalladaipuâ€.
Naadi & Manikkadai nool may be considered for
the diagnosis of “Azhal Kalladaipu†|
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 Azhal kalladaipu
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)
|
10/08/2023 |
| 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
|
None yet |
|
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 "Azhal Kalladaipu" (Renal Calculi).
Assessment of other diagnostic methods such as Naadi Nadai (Siddha Pulse diagnostic method) and Manikkadai Nool is also done. |