| CTRI Number |
CTRI/2024/06/068584 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An interventional clinical study of comparative effect of Durva and Gandhak ointment in the selected participants of eczema |
|
Scientific Title of Study
|
A comparative clinical study of Durva Malahara and Gandhakadya Malahara in the management of Eczema |
| 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 Bansi B Monpara |
| Designation |
PG scholar |
| Affiliation |
Maganbhai Adenwala Mahagujarat University |
| Address |
Department of Dravyaguna, J S Ayurveda Mahavidhyalay, college road, Nadiad
Maganbhai Adenwala Mahagujarat University, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9033714371 |
| Fax |
|
| Email |
bansimonpara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rejukrishnan |
| Designation |
Professor |
| Affiliation |
Maganbhai Adenwala Mahagujarat University |
| Address |
Department of Dravyaguna, J S Ayurveda Mahavidhyalay, college road, Nadiad
Maganbhai Adenwala Maganbhai University, College road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9066030409 |
| Fax |
|
| Email |
rejukrishnanr50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bansi B Monpara |
| Designation |
PG scholar |
| Affiliation |
Maganbhai Adenwala Mahagujarat University |
| Address |
Department of Dravyaguna, J S Ayurveda Mahavidhyalay, college road, Nadiad
Maganbhai Adenwala Mahagujarat University, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9033714371 |
| Fax |
|
| Email |
bansimonpara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda pharmacy, J S Ayurveda Mahavidhyalay, college road , Nadiad, India - 387001 |
|
|
Primary Sponsor
|
| Name |
Dr Bansi Monpara |
| Address |
Department of Dravyaguna, J S Ayurveda Mahavidhyalay, college road, Nadiad 387001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Bansi B Monpara |
P D Patel Ayurveda Hospital |
OPD No. 101, Kayachikitsa department
Kheda
GUJARAT |
9033714371
bansimonpara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maganbhai Adenwala Mahagujarat University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L20-L30||Dermatitis and eczema. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gandhakadya malahara, Reference: Rasatarangini ashtamatarang , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: durva malahara, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between age group of 16-60 years.
2) Patients having minimum 3-4 signs and symptoms of eczema fulfilling the diagnosis. |
|
| ExclusionCriteria |
| Details |
1) Patients having any other diseases like AIDS, STD, TB, DM and other disorders
which lead to fatal condition for the patients.
2) Pregnant and lactating women.
3) Patients who are on corticosteroid drugs or immune-suppressants and past history of
steroidal use in the last 6 months.
4) Other concomitant skin disease occurring with allergic reaction of any other disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in itching, discolouration, crusting, dryness, scaling, burning sensation |
Before and after the intervention of trial drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in EASI score |
Before and after the intervention of trial drug |
|
|
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)
|
01/07/2024 |
| Date of Study Completion (India) |
17/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted in form of dissertation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Eczema is a chronic, relapsing, and itchy inflammatory skin condition characterized by erythema, oedema, vesicles, weeping and skin thickening. 30 patients of eczema fulfilling inclusion criteria were selected from OPD and 15 patients each were allocated into group A and group B on the basis of block randomization. Durva malahara and Gandhakadya Malahara were administered to group A and group B respectively for externally for 6 weeks and the assessemnet was made through changes in signs-symptoms and EASI score of eczema. Both groups showed significant improvement in sign-symptoms and EASI score of eczema. Group A showed better improvement in erythema and oedema while group B showed slightly better improvement in excoriation and lichenification however the difference in signs of EASI score was not strong enough to confirm the real difference between the treatments of both group which showed statistically not significant result. |