| CTRI Number |
CTRI/2019/06/019715 [Registered on: 17/06/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identify the disease Peenisam(Sinusitis) through the wrist circumference measurement |
|
Scientific Title of Study
|
A Pilot clinical trial to determine the Manikkadainool measurement in Peenisam(Sinusitis) at National Institute of Siddha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VASANTHA S |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal National Institute of
Siddha Tambaram Sanatorium
Department of Noi Naadal National Institute of
Siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8675059800 |
| Fax |
|
| Email |
vasanthasks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal National Institute of Siddha Tambaram
Sanatorium Chennai
Department of Noi Naadal National Institute of Siddha 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 |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal National Institute of Siddha Tambaram
Sanatorium Chennai
Department of Noi Naadal National Institute of Siddha Tambaram
Sanatorium Chennai
Coimbatore
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 |
Ayothidoss Pandithar Hospital |
| Address |
Department of Noi Naadal National Institute of Siddha 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 S Vasantha |
Ayothidoss Pandithar Hospital |
Department of Noi
Naadal National
Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU |
8675059800
vasanthasks@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: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients who diagnosed with Peenisam(Sinusitis) at National Institute of Siddha OPD |
|
| ExclusionCriteria |
| Details |
Any deformity in the hand and forearm
Any serious illness
Co-morbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Finding of specific Manikkadainool measurement range for Peenisam and correlate with the textual reference range |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding of specific Manikkadainool measurement range for Peenisam and correlate with the textual reference range |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/06/2019 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Manikkadai nool is one of the diagnostic and prognostic tool in Siddha system of medicine. It is cost effective non invasive tool for diagnosis.To determine the diagnostic and/or prognostic significance of manikkadai nool in Siddha system of medicine. started to recruiting |