| CTRI Number |
CTRI/2017/04/008437 [Registered on: 28/04/2017] Trial Registered Prospectively |
| Last Modified On: |
27/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Pilot study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Herbal medicine for fungal infection |
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of siddha herbal formulation of Sarakondrai ennai (external medicine) for the management of padar thamarai (tinea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thilagavathi |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam op no 1 National institute of siddha
Tambaram sanatorium
Chennai-47
Department of maruthuvam op no 1 National institute of siddha
Tambaram sanatorium
Chennai47
Chennai
TAMIL NADU
600047
India |
| Phone |
9500577305 |
| Fax |
|
| Email |
thilagasampathh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HNalini sofia |
| Designation |
Lecturer |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam National institute of siddha
Tambaram sanatorium
Chennai47
Department of maruthuvam National institute of siddha
Tambaram sanatorium
Chennai47
Chennai
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
dr.nalinisofiah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HNalini sofia |
| Designation |
Lecturer |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam National institute of siddha
Tambaram sanatorium
Chennai47
Department of maruthuvam National institute of siddha
Tambaram sanatorium
Chennai47
Chennai
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
dr.nalinisofiah@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
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 |
| Thilagavathi |
National institute of Siddha |
National institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU |
9500577305
thilagasampathh@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 |
Marked itching,well defines raised margin,typical distribution of tinea lesions on the face,axilla,body,inguinal regions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Sarakondrai ennai |
External medicine sufficient quantity for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Typical distribution of the tinea lesions on the face,axilla,body,inguinal region.
Well defined raised margin.
Marked itching |
|
| ExclusionCriteria |
| Details |
Lesions with secondary infections.
H/o any other systemic diseases.
H/o VDRL positive cases.
H/o diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Grade 1-turning to normal skin,Grade 2- reduction of hyperpigmentation,Grade 3- reduction of size,Grade 4- reduction of itching,Grade 5-no improvement |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 1 |
|
Date of First Enrollment (India)
|
30/04/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Tinea or ringworm is a common skin infection and it affects people of all ages.Ringworm occurs when a particular type of fungus grows and multiplies anywhere on skin,scalp.In National Institute of Siddha considerable number of cases of tinea infection reported daily. With this background i have chosen this infection for pilot study.The bark and leaves of Cassia fistula has anti fungal activity.This Pilot study is to evaluate the therapeutic efficacy of siddha herbal formulation sarakondrai ennai (Cassia fistula oil ) as external medicine for tinea infection. |