| CTRI Number |
CTRI/2023/03/050626 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Doorvadi Cream In Atopic Dermatitis (Paridagdha Chavi) in Childrens
A single group study |
|
Scientific Title of Study
|
Evaluation Of Efficacy Of Doorvadi Cream In Paridagdha Chavi W.S.R To Atopic Dermatitis In
Paediatric Age Group-A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeraj Kumar Gupta |
| Designation |
Associate professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
Department of kaumarbhrity
Parul institute of ayurveda
Parul university
waghodia
vadodra gujrat
Department of kaumarbhrity
Faculty of Ayurveda
Mahayogi Gorakhnath University
Arogyadham Balapar Road
Sonbarsa Gorakhpur 273007 Uttar Pradesh
Vadodara
GUJARAT
391760
India |
| Phone |
9650970307 |
| Fax |
|
| Email |
neeraj.bvp.coa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Kumar Gupta |
| Designation |
Associate professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
Department of kaumarbhrity
Parul institute of ayurveda
Parul university
waghodia
vadodra gujrat
Department of kaumarbhrity
Faculty of Ayurveda
Mahayogi Gorakhnath University
Arogyadham Balapar Road
Sonbarsa Gorakhpur 273007 Uttar Pradesh
Vadodara
GUJARAT
391760
India |
| Phone |
9650970307 |
| Fax |
|
| Email |
neeraj.bvp.coa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
Department of kaumarbhrity
Parul institute of ayurveda
Parul university
waghodia
vadodra gujrat
Department of kaumarbhrity
Faculty of Ayurveda
Mahayogi Gorakhnath University
Arogyadham Balapar Road
Sonbarsa Gorakhpur 273007 Uttar Pradesh
Vadodara
GUJARAT
391760
India |
| Phone |
9650970307 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Mahant Digvijaynath Ayurveda Chikitsalaya
Faculty of Ayurveda Mahayogi Gorakhnath University
Arogyadham Balapar Road,
Sonbarsa Gorakhpur 273007 Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Mahant Digvijaynath Ayurved Chikitsalaya |
| Address |
Department of kaumarbhrity
Faculty of Ayurveda
Mahayogi Gorakhnath University
Arogyadham Balapar Road
Sonbarsa Gorakhpur 273007 Uttar Pradesh |
| Type of Sponsor |
Private 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 |
| Dr Neeraj Kumar Gupta |
Mahant Digvijaynath ayurveda chikitsalaya |
Arogyadham, Balapar Road Sonbarsa, Gorakhpur-273007 Uttar Pradesh
Gorakhpur
UTTAR PRADESH |
9650970307
neeraj.bvp.coa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, faculty of ayurved, mahayogi Gorakhnath university |
Approved |
| Parul institute of ayurveda Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Doorvadi Cream , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -It is a Developed Cream of classical lepa, So their is noBhaishajya kala for tropical application of cream |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1- Pre diagnosed case of atopic dermatitis
2- Having mild and moderate atopic dermatitis
according to TIS Scoring
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria are as follows: (1) lesions with oozing, (2) oral administration of corticosteroids, immunosuppressant’s, or antibiotics 4 weeks prior to study entry, (3) administration of topical glucocortecoids, immunosuppressant’s, or antibiotics, or phototherapy, 2 weeks prior to study entry, (4) burn or trauma on the lesions, (5) active skin diseases without AD, (6) renal or liver dysfunction, (7) other uncontrolled chronic diseases, (8) participation in other clinical trials within 1 month of enrollment, (9) inability to understand the written consent or to engage in this study due to mental impairment or other emotional or mental problems, and (10) judgment by experts that the potential subject’s participation is inappropriate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced redness |
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TIS score reduced |
15th & 45th day |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
20/03/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atopic dermatitis (AD) is the most common chronic inflammatory
skin disorder in children the prevalence of AD has almost tripled in industrialized
countries during last three decade Approximate 15%-30% children are affected.
Approximately 45% of cases of atopic dermatitis begin within 6 month of life 60%
begins during first year 85% begins before 5 year of age. Up to 70% of children
have a reemission before adolescence.
The
number of AD patient is beyond the level that can be dealt with at
clinics and it is time to make an effort to
reduce the number of AD patients in the community
The introduction of topical steroids of varying
potency has rendered the therapy of inflammatory coetaneous disorders more
effective and less time-consuming. However, the usefulness of these has become
a double edged sword with constantly rising instances of abuse and misuse
leading to serious local, systemic and psychological side effects. Cornerstone of therapy of AD is tropical different
formulation because impaired skin barrier is pivotal in the pathogenesis of AD.
So it is a need of more radical approach through ayurveda to manage AD
with no side effect with help of herbal medicine in the form of cream make the
herbal barrier on impaired skin |