| CTRI Number |
CTRI/2023/11/060215 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
23/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial on Fungal infections |
|
Scientific Title of Study
|
A randomised clinical trial on Tinea infections with the intervention of Gandhaga rasaayanam, Nilaavaarai choornam and Nilaavaarai gel among patients attending skin special OPD of Government Siddha Medical College Hospital, Chennai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJSamooga Neethi |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical College |
| Address |
Department of Siddha Pathology
Government Siddha Medical College
Arumbakkam
Chennai
6 Anna Arch Rd
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
7667778917 |
| Fax |
|
| Email |
dr.samooganeethi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBarathi Kannamma G |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical College |
| Address |
Department of Siddha Pathology
Government Siddha Medical College
Arumbakkam
Chennai
6, Anna Arch Rd
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9994245311 |
| Fax |
|
| Email |
barathi097@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBarathi Kannamma G |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical College |
| Address |
Department of Siddha Pathology
Government Siddha Medical College
Arumbakkam
Chennai
6, Anna Arch Rd
NSK Nagar
Arumbakkam
TAMIL NADU
600106
India |
| Phone |
9994245311 |
| Fax |
|
| Email |
barathi097@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Chennai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
6 NSK Nagar
Arumbakkam
Chennai |
| 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 |
| DrJSamoogaNeethi |
Government Siddha Medical College |
Skin Special OPD, Anna Arch Rd, NSK Nagar, Arumbakkam
Chennai
TAMIL NADU |
7667778917
dr.samooganeethi@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: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gandhaga rasaayanam (internal) and Nilaavaarai gel (external) |
Gandhaga rasayanam
500 mg oral BD for 3 months
Nilaavaarai gel
Topical application once in a day for 3 months |
| Comparator Agent |
Nilaavaarai choornam (internal) and Nilaavaarai gel (external) |
1 gram, Bd |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the clinical features of pruritus with well dermarcated circumscribed mild erythematous annular scaly plaques with raised edges and central clearing on the body.
Especially affecting the groin, initially appearing along the crural fold,pubic region and adjacent thighs and extend outwards (Tinea cruris) / Appearing over the trunk of the body (Tinea corporis) |
|
| ExclusionCriteria |
| Details |
Tinea infections other than Tinea cruris and corporis
Pregnant and lactating women
Individuals those who are under immunosuppressive drugs
Known HIV infected individuals
Known patients of uncontrolled diabetes mellitus (Hba1c >9) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tinea infections will be effectively treated by the trial drugs |
12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical features of Tinea infections will be effectively reduced when treated with external application of Nilaavarai gel |
6months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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
|
Among many patients attending skin special OPD, a significant number falls under Tinea infectios, so it is the need of an hour to provide a better choice for them. Padarthamarai perunoi (Tinea cruris and Tinea corporis) will be effectively treated with the selected trial drugs. It will be beneficial to the society by availing this trial medicines in skin special OPD. |