| CTRI Number |
CTRI/2019/03/018294 [Registered on: 28/03/2019] Trial Registered Prospectively |
| Last Modified On: |
28/03/2020 |
| 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 Karveeradya taila as medicine in Eczema in comparison to Clobetasol propionate with Emollient. |
|
Scientific Title of Study
|
A standard controlled clinical study of Karveeradya taila and Clobestol propionate with Emollient in management of garvishajanya Vicharchika with special reference to Eczema. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Drushti Jayesh Raval |
| Designation |
PG final year |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi |
| Address |
Ayurved rugnalay and Sterling multi speciality Hospital Sect no 27 Pradhikaran Nigdi,Pune
Department Agadtantra OPD NO. 125
Pune
MAHARASHTRA
411044
India |
| Phone |
9579661858 |
| Fax |
|
| Email |
dr.drushtiraval@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayant Phadke |
| Designation |
HOD Agadtantra Department |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi |
| Address |
Ayurved rugnalay and Sterling multi speciality Hospital Sect no 27 Pradhikaran Nigdi,Pune
Department Agadtantra OPD NO. 125
Pune
MAHARASHTRA
411044
India |
| Phone |
9822615265 |
| Fax |
|
| Email |
jayantphadke10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayant Phadke |
| Designation |
HOD Agadtantra Department |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi |
| Address |
Ayurved rugnalay and Sterling multi speciality Hospital Sect no 27 Pradhikaran Nigdi,Pune
Department Agadtantra OPD NO. 125
Pune
MAHARASHTRA
411044
India |
| Phone |
9822615265 |
| Fax |
|
| Email |
jayantphadke10@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre Sector 25 Pradikaran Nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
Sector number 25 Pradhikaran Nigdi Pune |
| 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 Drushti Jayesh Raval |
Ayurved and Sterling Multispeciality Hospital |
Vitthal Rukmai rd
Sector no 27
Pradhikaran Nigdi
name of opd Agadtantra
OPd no 125
Pune
MAHARASHTRA |
9579661858
dr.drushtiraval@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local application of Karveeradya taila |
Group A of 33 people having Garvishajanya Vicharchika will be given Karveeradya taila for local application for 21 days |
| Comparator Agent |
Local application Clobetasol propionate with Emollient |
Group B of 33 people having Garvishajanya vicharchika will be given Clobetasol propionate with Emollient for local application for 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with history of viruddha ahar sevan.
2.Patient with symptoms of Vicharchika |
|
| ExclusionCriteria |
| Details |
Known case of Diabetis mellitus,HIV
Any type of secondary infection at site like infection.
Known case of Pittaj vicharchika |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Karveradya taila in Garvishajanya Vicharchika comparison with Clobetasol propionate with special reference to Eczema |
Daily twice in a day for 21 days.
Follow up on 7,14,21 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To apply Karveeradya taila and see its effect.
2.To apply clobetasol propionate and see its effect.
3.To apply Karveeradya taila and Clobetasol propionate as per signs and symptoms.
4.To observe the adverse effect of drug, if any |
Daily twice in a day for 21 days.
Follow up On 7,14,21 day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Skin is largest organ and protective organ of the body. In Ayurveda skin is described as one of the panchdyanendriya. Skin disease causes psychological,physical and economical handicapping of the patient , as it is visible. Vicharchika is described as type of Kshudra Kusta in Ayurveda and Garvisha is described as one of its cause. Constant intake of viruddha anna leads to formation of Garvisha. Changing dietary habit and lifestyle has become the main cause in increase of skin diseases. Eczema is a skin disease which has classical symptoms like itching,discolouration,pain and lichenification. In modern medicine application of corticosteroid with emollient which gives symptomatic treatment but karveeradya taila is found to be effective in management of Garvishjanya vicharchika.Hence the trail is conducted. |