| CTRI Number |
CTRI/2021/08/035999 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
06/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of raja amirthathi chooranam (internal) and karappan ennai (external) for the managaement of balakarappan(atopic dermatitis) in children |
|
Scientific Title of Study
|
Clinical evaluation of raja amirthathi chooranam (internal ) and karappan ennai (external) for the managaement of balakarappan in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Praveena |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 9
Department of kuzhandhai maruthuvam
Nationala institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840431537 |
| Fax |
|
| Email |
drpraviseenu96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Vennila |
| Designation |
Associate professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 9
Department of kuzhandhai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9789093986 |
| Fax |
04422381214 |
| Email |
gvennils@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Praveena |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 9
Department of kuzhandhai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840431537 |
| Fax |
|
| Email |
drpraviseenu96@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD Ayothidass Pandithar Hospital
National institute of siddha |
|
|
Primary Sponsor
|
| Name |
OPD Ayothidass Pandithar hospital National institute of siddha |
| Address |
Room no 9
Department of kuzhandhai maruthuvam
National institute of siddha
Tambaram sanatorium |
| 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 |
| Dr S Praveena |
Ayothidass Pandithar hospital National institute of siddha |
Room no 9
Department of kuzhandhai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU |
9840431537
drpraviseenu96@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 |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Raja amirthathi choornam (internal)
Karappan ennai (external) |
Raja amirthathi choornam is given with water ,twice a day for 45 days
Dosage
7 years - 350 gms
8 -12 years -500 gms
Karappan ennai is appiled externally in needed quantity for 45 days. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children with one or more of the following symptoms
Itching
Erythema
Oedema
Oozing
Crusting and scaling
Lichenified plaque |
|
| ExclusionCriteria |
| Details |
Psoriasis
Scabies
Photo dermatitis
Fungal and parasitic skin infections
Any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of the trial drug is measured by using EASI score
and improvement in the clinical conditions will be observed |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the recurrence of the disease and improvement in the quality of life of children |
Before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/09/2021 |
| Date of Study Completion (India) |
20/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/05/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)?
Response - NO
|
|
Brief Summary
|
Atopic dermatitis or Eczema is the most common chronic relapsing skin disease seen in infancy and childhood.It is compared with bala karappan in siddha literature. So I have choosen siddha drug formulation Raja amirthathi choornam ( internal) and Karappan ennai (external) to treat the above ailment from authenticated sasthric siddha literature. |