| CTRI Number |
CTRI/2024/06/068704 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Sivanarvembu kuzhithylam for Tinea pedis |
|
Scientific Title of Study
|
Effectiveness of Sivanarvembu kuzhithylam for athletes foot( Tinea pedis ) among patients attending OPD at GSMCH chennai - A pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E Suganthira priya |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical College, Chennai |
| Address |
Department of PG Gunapadam, Government siddha medical College, Arumbakkam chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9626032022 |
| Fax |
|
| Email |
priyaelumalaibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MD Saravanadevi |
| Designation |
Professor, Department of PG Gunapadam |
| Affiliation |
Government siddha medical College Chennai |
| Address |
Department of PG Gunapadam, Government siddha medical College, Arumbakkam,chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444693840 |
| Fax |
|
| Email |
saravanadhevi1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MD Saravanadevi |
| Designation |
Professor, Department of PG Gunapadam |
| Affiliation |
Government siddha medical College Chennai |
| Address |
Department of PG Gunapadam, Government siddha medical College, Arumbakkam,chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444693840 |
| Fax |
|
| Email |
saravanadhevi1965@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arignar Anna government siddha medical College,No-6 , Anna arch road, Arumbakkam Chennai-600106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical College, Chennai -600106 |
| Address |
No-6, Anna arch road, Arumbakkam chennai-600106 |
| Type of Sponsor |
Government medical college |
|
|
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 ESuganthira priya |
Government siddha medical College, Chennai |
Department of PG Gunapadam, Government siddha medical College, Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
9626032022
priyaelumalaibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Arumbakkam , Chennai Arumbakkam, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sivanarvembu kuzhithylam |
Sivanarvembu kuzhithylam for Tinea pedis, External application, Twice a day for 40 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are having classical symptoms like itching, redness, burning,scaly rash and stinging pain in the foot.Patients who are willing to give specimen for the investigation required. Patients who are willing to provide photograph before and after treatment. |
|
| ExclusionCriteria |
| Details |
Any history of trauma and diabetes.Patients having diseases like Plantar psoriasis,Plantar eczema,palmoplantar keratoderma.Patients who are not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Sivanarvembu kuzhithylam in treating Tinea pedis. |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical symptoms with the photo assessments of before and after treatment. |
40 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Tinea is a fungal infection of the skin.It’s caused by different species of fungi.Tinea infection can affect any part of the body.But it most often occurs on the feet, groin,nails, body and scalp.The fungus is very contagious and can be spread from person to person.So it’s considered to evaluate the efficacy of Sivanarvembu kuzhithylam in treating Athlete’s foot.This study is designed the reduction in clinical symptoms with the photo assessments of before and after treatment. |