| CTRI Number |
CTRI/2019/05/019123 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical evaluation of Parangichakkai chooranam (internal) and Karappan ennai(external)in the treatment of Balakarappan(Atopic dermatitis) in children. |
|
Scientific Title of Study
|
Clinical Evaluation of PARANGICHAKKAI CHOORANAM(Internal) and KARAPPAN ENNAI(External)in the treatment of BALAKARAPPAN (Atopic dermatitis) in children. |
| Trial Acronym |
Atopic dermatitis |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSKalaivani |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of kuzhandhai maruthuvam,
Ayothidoss pandithar hospital,
National institute of siddha
Tambaram sanatorium,chennai,
kancheepuram-600047
Department of kuzhandhai maruthuvam,
Ayothidoss pandithar hospital,
National institute of siddha,
Tambaram sanatorium, chennai,
kancheepuram -600047
Kancheepuram
TAMIL NADU
04422381314
India |
| Phone |
9790146119 |
| Fax |
04422381314 |
| Email |
drkalaivanibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMMeenakshi sundaram |
| Designation |
Head of the Department |
| Affiliation |
NationaL Institute of siddha |
| Address |
Department of kuzhandhai maruthuvam,
Ayothidoss pandithar hospital,
National institute of siddha,
Tambaram sanatorium,chennai
kancheepuram -600047
Department of kuzhandhai maruthuvam,
Ayothidoss pandithar hospital,
National institute of siddha,
Tambaram sanatorium,chennai
kancheepuram -600047
Kancheepuram
TAMIL NADU
04422381314
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMMeenakshi sundaram |
| Designation |
Head of the Department |
| Affiliation |
NationaL Institute of siddha |
| Address |
Department of kuzhandhai maruthuvam,
Ayothidoss pandithar hospital,
National institute of siddha,
Tambaram sanatorium,chennai
kancheepuram -600047
Department of kuzhandhai maruthuvam,
Ayothidoss pandithar hospital,
National institute of siddha,
Tambaram sanatorium,chennai
kancheepuram -600047
Kancheepuram
TAMIL NADU
04422381314
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar hospital |
| Address |
National institute of siddha
Tambaram sanatorium
kancheepuram |
| Type of Sponsor |
Other [research student] |
|
|
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 |
| drskalaivani |
Ayothidoss pandithar hospital |
Department of kuzhandhai maruthuvam,Ayothidoss pandithar hospital,National institute of siddha,Tamabaram sanatorium,chennai
Kancheepuram
TAMIL NADU |
9790146119
04422381314
drkalaivanibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
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 |
NIL |
NIL |
| Intervention |
parangichakkai chooranam(internal) and karappan ennai(external) |
parangichakkai chooranam,5to6 years-1.3gm,7to12years-2gm will be administrated orally,afterfood twice a day and karappan ennai( required quantity) will be applied extrenally in the affected areas. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children of both sexes in the age group of 5 to 12 years with symptoms of:
1.Erythema
2.Edema
3.Oozing
4.Itching
5.Crusting and Scaling
6.Lichenified plaque |
|
| ExclusionCriteria |
| Details |
1.Scabies
2.photodermatitis
3.Fungal and parasitic skin infection
4.Psoriasis
5.Any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of Parangichakkai chooranam (Internal) and Karappan ennai(external)in the treatment of Balakarappan(Atopic dermatitis) using EASI Score |
1 to 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to standardize the physico chemical properties of the trial drugs.
To study the effect of trial drug in reducing the frequency of incidence ofBalakarappan |
3 months |
|
|
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)
|
20/05/2019 |
| Date of Study Completion (India) |
06/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
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
|
IT Is a single non randomized open -label trial to determine the efficacy of PARANGICHAKKAI CHOORANAM (internal medicine) with KARAPPAN ENNAI (external medicine) in patients with BALAKARAPPAN(Atopic dermatitis). In the trial 30 Atopic dermatitis patients will be recruited and the trial drug parangichakkai chooranam , 5 to 6 years -1.3gm and 7 to 12 years -2gm, will be administrated orally after food twice a day and karappan ennai ( required quantity) will be applied for affected skin for a periods of 45 days.During the study period all the study related data will be recorded and documented in separate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman, pharmaco- vigilance committee, NIS. If it will be mild event , the patient will be treated in OPD-NIS. If thr event will be reserve , the patient will be reffered to nearby Government Hospital and investigator will be take over the patient,until he/she will get recovery. the treatment will be provided with free of cost. the entire trial will be monitored by the research monitoring committee of NIS. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in Indian journal of Medicial research. |