| CTRI Number |
CTRI/2024/12/078826 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of kustha(atopic dermatitis) in children |
|
Scientific Title of Study
|
A CILINICAL COMPARATIVE STUDY OF HARIDRA KHANDA + GANDHAKA MALAHARA (L.A.) AND LAGHU MANJISTHA GHANVATI + GANDHAKA MALAHARA (L.A) IN THE MANAGEMENT OF KUSTHA (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 |
DrZankhanaben R Zankat |
| Designation |
P G Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7096673684 |
| Fax |
|
| Email |
zankhanazankat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maleka Vhora |
| Designation |
Associate professor Department of Kaumarbhritya |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9978767460 |
| Fax |
|
| Email |
maleka23vhora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maleka Vhora |
| Designation |
Associate professor Department of Kaumarbhritya |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9978767460 |
| Fax |
|
| Email |
maleka23vhora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda teaching pharmacy of J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarbhritya,J S Ayurveda Mahavidyalaya, College road, Nadiad-387001 |
| 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 Zankhanaben R Zankat |
P D Patel Ayurveda Hospital |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001
Kheda
GUJARAT |
7096673684
zankhanazankat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAM UNIVERSITY- NADIAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laghu Manjisthadi Ghanavati, Reference: Sharangdhara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Gandhaka Malahara, Reference: Rasatarangini, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra Khanda, Reference: Bhaisajya ratnavali, Route: Oral, Dosage Form: Khanda /Granules, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Gandhaka Malahara, Reference: Rasatarangini, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of age group 2 years to 16 years will
be included irrespective of religion, gender and
socio-economic status.
2.Participants diagnosed with Lakshana of kustha
will be included for the study.
3.Participants having the clinical features of
acute & sub acute atopic dermatitis will be
included.
|
|
| ExclusionCriteria |
| Details |
1.Participants below the age of 2 years and above
the age of 16 years will be excluded.
2.Chronic atopic dermatitis(more than 1 year) will
be excluded.
3.Atopic dermatitis associated with secondary
bacterial infection.
4.Child presenting any other associated systemic
symptoms like diarrhoea, acute respiratory
infection and acute febrile conditions will be
excluded.
5.Participant having cracked skin will be excluded for the local application of Gandhaka Malahara.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out changes in symptoms of Kustha(Atopic dermatitis) by recording them before and after administration of treatment. |
Baseline 2weeks (during treatment) and 4weeks(after treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess standerd scorad index of atopic dermatitis |
Baseline 2weeks (during treatment) and 4weeks(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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/04/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Atopic dermatitis can cause social stigma and negatively affect a child’s psychological and social well being. Current treatment mainly provides symptomatic relief with recurrence after discontinuation. There fore an effective and sustainable treatment approach is needed. Both groups showed significant improvement in SCORAD, itching, dryness with greater relief in group A. Redness did not improve significantly. Both treatment were safe, with no adverse effects. Larger long term studies are recommended to confirm these findings. |