| CTRI Number |
CTRI/2022/05/042504 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
11/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of shirish twaka ghrita application in treatment of atopic dermatitis |
|
Scientific Title of Study
|
Comparative clinical study of efficacy of shrish twaka ghrita application with clobetasole ointment (clobetasole propionate) in management of charmadala in children with special reference to atopic dermatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepesh Naik |
| Designation |
PG Scholar |
| Affiliation |
School Of Ayurveda, D.Y. Patil Deemed To Be University |
| Address |
Kaumarbhritya Department, School Of Ayurveda, D.Y. Patil Deemed To Be Universuity, Nerul, Navimumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
7709904111 |
| Fax |
|
| Email |
dipeshnaik76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kalpana dhuri |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
D.Y Patil Deemed to be University |
| Address |
Kaumarbhritya Department, School Of Ayurveda, D.Y. Patil Deemed To Be Universuity, Nerul, Navimumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepesh Naik |
| Designation |
PG Scholar |
| Affiliation |
School Of Ayurveda, D.Y Patil Deemed To Be University. |
| Address |
Kaumarbhritya department, School Of Ayurveda, D.Y. Patil Deemed To Be Universuity, Nerul, Navimumbai, Thane.
Thane
MAHARASHTRA
400706
India |
| Phone |
7709904111 |
| Fax |
|
| Email |
dipeshnaik76@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Ayurveda, D. Y. PATIL Deemed TO Be University, Nerul, Navimumbai |
|
|
Primary Sponsor
|
| Name |
Dr Deepesh Naik |
| Address |
Kaumarbhritya department, school of ayurveda, D.Y. Patil deemed to be universuity, Nerul, Navimumbai |
| 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 Deepesh Devraj Naik |
School Of Ayurveda, D.Y. Patil Deemed To Be University, Nerul,Navimumbai. |
kaumarbhritya Department - Balrog,School Of Ayurveda,D.Y. Patil Deemed To Be University, Nerul,Navimumbai.
Thane
MAHARASHTRA |
7709904111
dipeshnaik76@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: L00-L99||Diseases of the skin and subcutaneous tissue, (2) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: CARMADALA-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shrish twaka ghrita, Reference: charak chikitsa sthana - 7/96, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: It is advised to use shirish twaka lepa as external use. In this study shirish twak ghrita was selected for study in view of easy external application of ghrita as compared to lepa. | | 2 | Comparator Arm (Non Ayurveda) | | - | clobetesol propionate | Clobetasol Propionate is the propionate salt form of clobetasol, a topical synthetic corticosteroid with anti-inflammatory, anti-pruritic, and vasoconstrictive properties.
Dose: 0.05%
frequency and duration: local aplication over affected areas, twice a day.
|
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical signs and symptoms of charmadala.
|
|
| ExclusionCriteria |
| Details |
1]patient having any other type of kshudrakushtha or mahakushtha other than charmadala.
2]patients with complications of wheeping of affected part or infected lesions.
3]patient having other associated illness like diarhoea, acute respiratory infections and acute febrile or other disorders are excluded from the study.
4]patient with sever form of other systemic and metabolic disorders.
5]HIV ad HbSAg positive patients.
6]allergic reactions to systemic/topical study drugs |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the clinical efficacy of shrish twaka ghrita application in management of charmadala in kaumar awastha.
The changes observed after treatment will be assessed on the basis of reduction in following signs and symptoms- kandu(itching), discharge(strava), vaivarnyata(disccolouration), daha(burning sensation), rukshata(dryness).
|
0-60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the clinical efficacy of Clobetasole Proprionate ointment in management of Charmadala in kaumar-awastha
2. To study the pathophysiology of Charmadala in kaumar-awastha
The changes observed after treatment will assessed on the basis of reduction in following signs and symptoms-
1]Kandu(itching)
2]Discharge(strava)
3]Vaivarnyata(discolouration)
4]Daha(burning sensation)
5]Rukshata(dryness)
The primary study outcomes arise from and align directly with the primary study aim or objective. Likewise, any secondary study outcomes arise from and directly align with any secondary study aim or objective
|
0-60 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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2022 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the present study is the clinical experimental study for completion under DY patil deemed to be university total duration of trail is 1.5 years
TITLE : Comparative clinical study to assess the efficacy of shrish twaka ghrita application and clobatesol propionate ointment in management of Charmadala in children w.s.r. Atopic dermatitis.
STUDY GROUP : sample size 30 will be treated with shrish twaka ghrita application and 30 will be treated with clobatesol propionate ointment application.
STUDY CENTRE : school of Ayurveda DY patil deemed to be university nerul, navimumbai.
PG SCHOLAR : Dr. Deepesh Devraj Naik
GUIDE : Dr. Kalpana Dhuri. |