| CTRI Number |
CTRI/2025/03/081521 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the number of children affected with atopic dermatitis and affect of ayurvedic compound Darvi Guduchyadi Navkarshik Kasahya Ghanvati and Aragvadhadi lotion reduce the skin infection (Atopic Dermatitis) in children. Also to study the various factors responsible for the skin AD in children. |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF DARVI
GUDUCHYADI NAVKARSHIK KASHAYA GHANVATI AND ARAGVADHADI LOTION IN THE MANAGEMENT OF VICHARCHIKA W.S.R. TO ATOPIC DERMATITIS IN CHILDREN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshani Bhatia |
| Designation |
MD Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
P.G. Department of kaumarbhritya Madan Mohan Malviya Government Ayurved College, Rada ji choraha,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829754268 |
| Fax |
|
| Email |
roshanibhatia40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kumar |
| Designation |
Professor and Head of department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
P.G. Department of kaumarbhritya Madan Mohan Malviya Government Ayurved College, Rada ji choraha,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005857838 |
| Fax |
|
| Email |
drbhamuramkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ram Kumar |
| Designation |
Professor and Head of department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
P.G. Department of kaumarbhritya Madan Mohan Malviya Government Ayurved College, Rada ji choraha,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005857838 |
| Fax |
|
| Email |
drbhamuramkumar@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Madan Mohan Malviya Government Ayurveda College, Udaipur Rajasthan, India, Pin code - 313001 Pharmacy. |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurveda College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurveda College, Rada ji circle,Ambamata,Udaipur, Rajasthan,India.Pin Code- 313001 |
| Type of Sponsor |
Government 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 Roshani Bhatia |
Campus hospital, Motichohatta hospital and Udaipur District |
Kaumarbhritya Opd no.4 in campus hospital and Opd no.3 in motichohatta hospital, Madan Mohan Malviya Government Ayurveda College, Udaipur(Rajasthan) 313001 Udaipur Rajasthan
Udaipur
RAJASTHAN |
9829754268
roshanibhatia40@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malviya Government Ayurveda College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Darvi Guduchyadi Navkarshik Kashaya Ghanvati , Reference: Sahastrya yoga kashaya prakarnama, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 350(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: -In group B only Darvi Guduchyadi Navkarshik Kashaya Ghanvati will be administered in 2- 16 years old children for 56 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvi Guduchyadi Navkarshik Kashaya Ghanvati, Reference: Sahastrya yoga kashaya prakarnama, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 350(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: Darvi Guduchyadi Navkarshik Kashaya Ghanvati and Aragvadhadi lotion will be given for 56 days
Dose - 5gm BD
Route- topical |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Children whose parents are willing to give consent/assent on clinical trial.
2 Children aged between 2 years to 16 years of either sex.
3 Mild to Moderate Atopic Dermatitis in affected area according to SCORAD (1-50).
4 Children having clinical signs and symptoms of Vicharchika (Atopic Dermatitis)
mentioned in Ayurvedic classics and modern texts.
5 Children having complain less than 5 years duration. |
|
| ExclusionCriteria |
| Details |
1 Children below the age of 2 years and above 16 years.
2 Children with illness greater than 5 years.
3 Severe Atopic Dermatitis having score greater than 50 in SCORAD.
4 Children with long term steroid and cytotoxic treatment.
5 Children suffering from any systemic disorders.
6 Vicharchika associated with immunodeficiency disorders such as HIV etc.
7 Vicharchika with any other secondary infection, psoriasis, urticaria etc.
8 Children with history of malignancy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical effectiveness and efficacy of both drugs |
56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the both drugs |
56 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/04/2025 |
| 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="0"
Months="7"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is conducted on atopic dermatitis (Vicharchika) in children on 60 cases, medicines administered will be Darvi Guduchyadi Navkarshik Kashaya Ghanvati and Aragvadhadi lotion. Two groups will be there :- 1. Group A - Darvi Guduchyadi Navkarshik Kashya Ghanvati and Aragvadhadi lotion 2. Group B - only Darvi Guduchyadi Navkarshik Kashaya Ghanvati will be given respectively. This study aims to check the efficacy of both the drugs so that effective treatment can be given. |