| CTRI Number |
CTRI/2014/04/004566 [Registered on: 24/04/2014] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical research of siddha medicine in the management of karappan(Eczema)
|
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of Gandhaga mezhugu and karappanukku ennai in the management of karappan |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTPriyadharsini |
| Designation |
PGscholar |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Sirappu Maruthuvam
National Institute of siddha
Tambaram Sanatorium
Chennai
National Institute of siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9094272416 |
| Fax |
04422381314 |
| Email |
priyathirugnanam86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGThiyagarajan |
| Designation |
HOD & GUIDE |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Sirappu Maruthuvam
National Institute of siddha
Tambaram Sanatorium
Chennai
National Institute of siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444170980 |
| Fax |
04422381314 |
| Email |
gtsiddha60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGThiyagarajan |
| Designation |
HOD & GUIDE |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Sirappu Maruthuvam
National Institute of siddha
Tambaram Sanatorium
Chennai
National Institute of siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444170980 |
| Fax |
04422381314 |
| Email |
gtsiddha60@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of siddha |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatirium
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 |
| DrTPriyadharsini |
National Institute of Siddha |
Department of Sirappu maruthuvam
National Institute of Siddha
chennai
Chennai
TAMIL NADU |
9094272416
04422381314
priyathirugnanam86@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 |
Eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gandhaga mezhugu (internal)and karappanukku ennai (external) |
Gandhaga mezhugu is a herbomineral formulation- 170mg -BD Dose oral route 15 days duration.
karappanukku ennai is a poly herbal formulation applied externaly for 30 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
willing to admitted in trial
patients with symptoms of eczema |
|
| ExclusionCriteria |
| Details |
pregnancy and lactation
hypertension
any other serious illness
varicose eczema |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcome is mainly assesses by reduction in EASI score |
outcome is mainly assesses by reduction in EASI score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of yogam in the treatment of eczema along with trial drug |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/12/2013 |
| 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) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the therapeutic efficacy of siddha herbomineral formulation gandhaga mezhugu and karappanukku ennai in the treatment of eczema , a chronic skin disease which can be effectively treated and managed with siddha medicines. And also to provide cost effective tereatment. to study the siddha basic principles such as envagai thervu , neerkuri , neikuri etc |