| CTRI Number |
CTRI/2020/06/025954 [Registered on: 17/06/2020] Trial Registered Prospectively |
| Last Modified On: |
13/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic trial |
| Study Design |
Other |
|
Public Title of Study
|
Eight fold examination(tongue, skin tone, voice tone, eyes, touch sensation, stools, urine, pulse) in the Diagnosis of Patha Vanmeegam (Lymphatic Filariasis) |
|
Scientific Title of Study
|
A Study on Envagai Thervu in the Diagnosis of Patha Vanmeegam (Lymphatic Filariasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Aruldevi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room number 5
Department of Noi Naadal
National Institute of Siddha
Tambaram sanatorium
Room number 5
Department of Noi Naadal
National Institute of Siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9750815569 |
| Fax |
22381314 |
| Email |
aruldevis94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Ramamurthy |
| Designation |
lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Room Number 5
Department of Noi Naadal
National Institute of Siddha
Tambaram sanatorium
Room Number 5
Department of Noi Naadal
National Institute of Siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9443178112 |
| Fax |
22381314 |
| Email |
ramsnis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Aruldevi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room Number 5
Department of Noi Naadal
National Institute of Siddha
Tambaram sanatorium
Room Number 5
Department of Noi Naadal
National Institute of Siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9750815569 |
| Fax |
22381314 |
| Email |
aruldevis94@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 S Aruldevi |
Ayothidoss Pandithar Hospital |
room 5
department of noinaadal
National Institute of Siddha
Kancheepuram
TAMIL NADU |
9750815569
22381314
aruldevis94@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: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Leg with Elephantiasis |
|
| ExclusionCriteria |
| Details |
Patient who is not willing to sign in Consent form.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Documentation of the Envagai Thervu in the disease Paatha Vanmeegam (LF) |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Documentation of the Envagai Thervu in the disease Paatha Vanmeegam (LF) |
18 months |
|
|
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)
|
01/08/2020 |
| 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="1"
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
|
This is the observational study in which 30 patients will be selected based on inclusion and exclusion criteria the data related to this study will be collected from each patients by using Envagai Thervu . All collected data will be entered into MS Excel Software. STATA Software will be used to perform statistical analysis . The percentage of the observed Eight Fold examination will be noted |