| CTRI Number |
CTRI/2023/08/056036 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Siddha and Modern investigatory tool Neerkuri and Neikuri in Madhu Piramiam(Diabetes Mellitus with Urinary Tract Infection |
|
Scientific Title of Study
|
An observational study on Siddha investigatory tool- Neerkuri and Neikuri and Modern investigatory tool- Urine Culture in Madhu Piramiam ( Diabetes Mellitus Urinary Tract Infection) and Line of Treatment with dietary regimen. |
| 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 Dhasarathan A D |
| Designation |
PG Scholar |
| Affiliation |
Goverment Siddha Medical College and Hospital |
| Address |
Department of Noi Naadal, Goverment Siddha Medical College and Hospital, Palayamkottai, Tirunelveli ,Tamil Nadu-627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072067470 |
| Fax |
|
| Email |
dhasarathanad8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balamurugan A |
| Designation |
Lecture Grade - II |
| Affiliation |
Goverment Siddha Medical College and Hospital |
| Address |
Department of Noi Naadal, Goverment Siddha Medical College and Hospital, Palayamkottai, Tirunelveli ,Tamil Nadu-627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balamurugan A |
| Designation |
Lecture Grade - II |
| Affiliation |
Goverment Siddha Medical College and Hospital |
| Address |
Department of Noi Naadal, Goverment Siddha Medical College and Hospital, Palayamkottai, Tirunelveli ,Tamil Nadu-627002.
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 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai, Tirunelveli, Tamil Nadu. |
| 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 A DDhasarathan |
Government siddha medical college and hospital, palayamkottai |
Room no 2, Department
of NoiNaadal,
Government siddha
medical college and
hospital, Palayamkottai,
Tirunelveli, TAMIL
NADU
Tirunelveli
TAMIL NADU
Tirunelveli
TAMIL NADU |
8072067470
dhasarathanad8@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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Blood sugar range (>126mg/dl in fasting & >200mg/dl in postprandial)
Dysuria
Urogenital discharge
Loss of body weight |
|
| ExclusionCriteria |
| Details |
BPH
Pregnancy
Ureter calculi
Other major illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Neerkuri(Siddha Urine analysis
methodology) & Neikuri patterns (Siddha Urine
analysis pattern) in MADHU PIRAMIAM patients at a
single visit. |
1 year 6 months |
|
|
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 MADHU PIRAMIAM
patients at a single visit. |
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)
|
07/08/2023 |
| 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
|
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 MADHU PIRAMIAM (DIABETES
MELLITUS WITH URINARY TRACT INFECTION).
Assessment of other diagnostic methods such as Naadi Nadai (Siddha Pulse diagnostic method)
and Manikkadai Nool is also done.
|