| CTRI Number |
CTRI/2016/06/006983 [Registered on: 02/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Evaluation of Vatha Karappan (Ecezma) |
|
Scientific Title of Study
|
A Clinical Evaluation of CHARANAI KUDINEER (Internal medicine) BOOTHAKARAPPANPATTAI ENNAI (External medicine) siddha drug for VATHA KARAPPAN in children on open clinical study |
| Trial Acronym |
Ecezma |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EINDUMATHI |
| Designation |
PGSCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
Ayothidass Pandithar
Hospital, Department of
kuzhandhai
maruthuvam, National
Institute of Siddha,
Tambaram Sanatorium,
Chennai-47
Ayothidass Pandithar
Hospital, Department of
kuzhandhai
maruthuvam, National
Institute of Siddha,
Tambaram Sanatorium,
Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9994594075 |
| Fax |
04422381314 |
| Email |
indumathi13887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMMeenakshi Sundaram |
| Designation |
Associate Proffesor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandhai Maruthuvam National Institute of Siddha
Tambaram Sanatorium Chennai National Institute of Siddha
Tambaram Sanatorium Chennai
Chennai
Department of Kuzhandhai Maruthuvam National Institute of Siddha
Tambaram Sanatorium Chennai National Institute of Siddha
Tambaram Sanatorium Chennai
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMMeenakshi Sundaram |
| Designation |
Associate Proffesor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandhai Maruthuvam National Institute of Siddha
Tambaram Sanatorium Chennai National Institute of Siddha
Tambaram Sanatorium Chennai
Chennai
Department of Kuzhandhai Maruthuvam National Institute of Siddha
Tambaram Sanatorium Chennai National Institute of Siddha
Tambaram Sanatorium Chennai
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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 |
| DrEIndumathi |
National Institute of Siddha |
Ayothidass Pandithar
Hospital, Department of
kuzhandhai
maruthuvam, National
Institute of Siddha,
Tambaram Sanatorium,
Chennai-47
Chennai
TAMIL NADU |
9994594075
04422381314
indumathi13887@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 |
Patients with symptoms of
Skin rashes or bumpy rashes or blisters,Papules, vesicles, pustules,, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHARANAI KUDINEER (Internal medicine) &
BOOTHAKARAPPANPATTAI ENNAI (External medicine) |
CHARANAI KUDINEER is a
poly herbal formulation 20 ml (b.d)duration of 14 days |
| Comparator Agent |
NA |
Na |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria 1. Age 7 to 12 years
2.Skin rashes or bumpy rashes or blisters,
Papules, vesicles, pustules,
Ulcer formation with oozing,
Swelling,
Pain,
Fever
3. Patients willing to give specimen of blood for investigation
when required.
4. Patients willing to be admitted in the hospital or willing to
attend OPD once in 7 days for 14 days |
|
| ExclusionCriteria |
| Details |
Scabies
Photo dermatitis
Patient with any other serious illness which needs
discontinuity of trial drug
Seborrhoeic dermatitis
Nummular dermatitis
Fungal or parasitic skin infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Good-reduced all clinical symptoms
Moderate-reduced some clinical symptoms
Poor-No improvement or change in clinical symptoms |
With in 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by therapeutic efficacy of the trial drugs |
1-3 months
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 polyherbal formulation Charanai kudineer (internal medicine) and Boothakarappan
pattai ennai (external medicine)in the treatment of Ecezma , I BELIVE IT WORK WELL
|