| CTRI Number |
CTRI/2020/06/026050 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
19/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Neikkuri( urine examination) in different containers to find out the differences |
|
Scientific Title of Study
|
A study on possible differential patterns of neikkuri findings with parallel testing of urine samples in bowls made of different materials |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gajalakshmi G |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
NO 5 department of Noinaadal, National Institute of Siddha, Tambaram Sanatorium, chennai 47
NO 5 department of Noinaadal, National Institute of Siddha, Tambaram Sanatorium, chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9489494387 |
| Fax |
22381314 |
| Email |
gajagaja8380@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan V |
| Designation |
lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
NO 5 department of Noinaadal, National Institute of Siddha, Tambaram Sanatorium, chennai 47
NO 5 department of Noinaadal, National Institute of Siddha, Tambaram Sanatorium, chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9965962992 |
| Fax |
22381314 |
| Email |
seenunis47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gajalakshmi G |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
NO 5 department of Noinaadal, National Institute of Siddha, Tambaram Sanatorium, chennai 47
NO 5 department of Noinaadal, National Institute of Siddha, Tambaram Sanatorium, chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9489494387 |
| Fax |
22381314 |
| Email |
gajagaja8380@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, chennai. |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar hospital, National Institute of Siddha,
Tambaram Sanatorium
chennai |
| 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 Gajalakshmi G |
Ayothidoss Pandithar Hospital |
no 5 department of Noinaadal, National institute of siddha, Tambaram Santorium, chennai
Kancheepuram
TAMIL NADU |
9489494387
22381314
gajagaja8380@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: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients of NIS opd or admitted ipd ward who have the complaints of Madhumegam without other co- morbidities |
|
| ExclusionCriteria |
| Details |
patients with MODS
Patients who have other Co morbidities with diabetes mellitus
age group below 18 above 80
who is not willing to giving urine sample |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| documentation of various patters of neikkuri in different materials of bowls |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/06/2020 |
| 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="6"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study in which 30 patients will be selected based on inclusion and exclusion criteria.The data will be collected from each patients.All collected data will be entered into MS excel software. STATA software will be used to perform statistical analysis. To determine the various patterns of the neikkuri findings in bowls made of different materials. |