| CTRI Number |
CTRI/2024/05/066740 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Neerkuri,Neikuri analysis in children for Soolikanam |
|
Scientific Title of Study
|
An Observational study of Standardization of Siddha diagnostic tool (Neerkuri Neikuri)in children with Bronchial Asthma( Soolikanam) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DSivasankari |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College,Chennai |
| Address |
Postgraduate Room no 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
09791747408 |
| Fax |
|
| Email |
sivasankarikamalanathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrCShanmugapriya MDS |
| Designation |
Assistant professor |
| Affiliation |
Government Siddha Medical College.Chennai |
| Address |
Postgraduate Room no 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
919445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DSivasankari |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College,Chennai |
| Address |
Postgraduate Room no 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
09791747408 |
| Fax |
|
| Email |
sivasankarikamalanathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Chennai-600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No.6 Anna Arch Road NSK Arumbakkam Chennai 600106 |
| Type of Sponsor |
Other [Government Siddha Medical College Chennai 600106] |
|
|
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 |
| Sivasankari |
Government Siddha Medical College |
Department of Kuzhanthai Maeuthuvam NSK Nagar Arumbakkam, Chennai TAMILNADU
Chennai
TAMIL NADU |
9791747408
sivasankarikamalanathan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Chest thightness,cough without expectoration, wheezing present. |
|
| ExclusionCriteria |
| Details |
Hypersensitivity of pneumonitis, Primary complex,Lung abscess,Cystitis fibrosis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Document NeerkuriAnd Neikuri Pattens of Bronchial Asthma in children |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will be helpful to create seperate data set for earlier diagnosis of Bronchial Asthma by using Siddha diagnostic tools Neerkuri ,Neikuri |
20 minutes |
|
|
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)
|
16/05/2024 |
| 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="0"
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
|
STANDARD OPERATING PROCEDURE FOR NEERKURI:
Patients reporting at OPD of AAGHIIM,Arumbakkam,will be enrolled in the study ,based on inclusion and exclusion criteria.Patients will be informed about the purpose of study.If the patient is willing ,their urine sample will be collected.
Sterile closed container is given for urine collection.Nirem,nurai,edai,manam and enjal are noted.
STANDARD OPERATION PROCEDURE FOR NEIKURI:
Early in the morning ,the patients were asked to collect the mid-stream urine of the first urination of the day in a clean and neat bottle.Urine thus collected was poured in a round wide mouthed glass bowl, kept on a flat surface and was allowed to stand.After ascertaining that the urine was still and devoid of disturbance or ripples or other influences of wind,then it was examined in a day light in morning.Sesame oil was then taken in a dropper and a drop of oil was instilled over the surface of the urine gently without disturbing or touching the surface.It was then left for a few minutes and the oil drop spreading pattern on the urine surface was observed.The observation were then recorded and the photography was taken.5 Slides of picture were taken-1 minute aftrr dropping of oil,after 3 minutes ,after 5 minutes ,after 7 minutes and after 10 minutes. |