| CTRI Number |
CTRI/2020/06/026175 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Urine examination and oil drop test(Neerkuri / Neikkuri) in Elaippu noi-Tuberculosis |
|
Scientific Title of Study
|
Neerkuri And Neikkuri examination in patients with Elaippu Noi (Tuberculosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K BIRABANCHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA, DEPARTMENT OF NOI NAADAL, TAMBARAM SANATORIUM, CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM,
CHENNAI - 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7395949362 |
| Fax |
|
| Email |
birabanchanakathir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
Head of Department, Dept of Noi Naadal |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA, |
| Address |
NATIONAL INSTITUTE OF SIDDHA, DEPARTMENT OF NOI NAADAL, TAMBARAM SANATORIUM, CHENNAI
NATIONAL INSTITUTE OF SIDDHA, DEPARTMENT OF NOI NAADAL, TAMBARAM SANATORIUM, CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G J Christian |
| Designation |
Head of Department, Dept of Noi Naadal |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA, |
| Address |
NATIONAL INSTITUTE OF SIDDHA, DEPARTMENT OF NOI NAADAL, TAMBARAM SANATORIUM, CHENNAI
NATIONAL INSTITUTE OF SIDDHA, DEPARTMENT OF NOI NAADAL, TAMBARAM SANATORIUM, CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram Sanatorium,
chennai - 47 |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
NATIONAL INSTITUTE OF SIDDHA, DEPARTMENT OF NOI NAADAL, TAMBARAM SANATORIUM, CHENNAI - 47 |
| 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 K BIRABANCHANA |
NATIONAL INSTITUTE OF SIDDHA |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM,
CHENNAI - 47
Kancheepuram
TAMIL NADU |
7395949362
birabanchanakathir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health volunteer |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Gender - Male, Female & Transgender
Patients who report at National Institute Of Siddha - outpatient, inpatient department and nearby govt hospital of thoracic medicine with diagnosis of Tuberculosis
|
|
| ExclusionCriteria |
| Details |
Patient not willing to give urine sample and sign the informed consent |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Documentation Of Various Patterns Of Neikkuri In Elaipu Noi (Tuberculosis) |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Documentation Of Specific Patterns Of Neikkuri In Elaipu Noi (Tuberculosis) If Present
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
29/06/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted as randomized control trial.The test and control groups will be
randomized according to the predrawn random number list. The sample size of the
study is 80 (Test group and control group). The test group is screened with the
inclusion and exclusion criteria by the research group then the patient is evaluated through Envagai
thervu (Naadi, sparisam, Naa, Niram, Mozhi, Vizhi, Malam, Moothiram). If enrolled, urine sample will be collected
and the Neikkuri procedure will be done in both group participants. The noted
Envagai Thervu (Eight Diagnostic tools) including Neerkuri and Neikkuri patterns will be
recorded. |