| CTRI Number |
CTRI/2024/02/062810 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Vamana Karma (Emesis)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Vamana Karma(Emesis) And Edgajadi Lepa(Local application) in Eczema. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Vamana Karma And Edgajadi Lepa In The Management Of Vicharchika With Special Reference To Eczema. |
| Trial Acronym |
Vaedvi |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Kanojia |
| Designation |
M.D. Scholar |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department Of Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8527657794 |
| Fax |
|
| Email |
kanojia.abhi247@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Nigam |
| Designation |
Lecturer, P.G. Department of Panchakarma |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department Of Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8948732899 |
| Fax |
|
| Email |
rachananigam19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Kanojia |
| Designation |
M.D. Scholar |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department Of Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8527657794 |
| Fax |
|
| Email |
kanojia.abhi247@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurveda College and Hospital Varanasi |
|
|
Primary Sponsor
|
| Name |
Government P.G. Ayurveda College and Hospital |
| Address |
Department Of Panchakarma,
Government P.G. Ayurveda College and Hospital, Varanasi |
| 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 Abhishek Kanojia |
Government P.G. Ayurveda College and Hospital |
Department Of Panchakarma
Government P.G. Ayurveda College And Hospital, Varanasi,UTTAR PRADESH
Varanasi
UTTAR PRADESH |
8527657794
kanojia.abhi247@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government P.G. Ayurveda College and Hospital, Varanasi, U.P. , Mahayogi Guru Gorakhnath Ayush University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (Procedure Reference: Charak chikitsa 7/43, Procedure details: Purvakarma- Deepana,Pachana,Snehana,Swedana
Pradhankarma- Vamana-Kutajadi yoga
Paschatkarma- Dhoompana,Sansarjana karma)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Chakradatta 50/38, Procedure details: Lepa- Edgajadi lepa to be applied locally.)
(1) Medicine Name: Edgajadi lepa, Reference: Chakradatta 50/38, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-60 years.
2. Patient presenting with Cardinal symptoms of Vicharchika.i.e. Kandu, Pidika , Shyavata
and srava.
3.Symptoms of eczema like itch, dryness, inflamed skin, oozing or crusting.
4.Patient voluntarily willing to participate in the trial.
• Immunosuppressive drug, corticosteroid as well as other modern medicine if any will be
tapped gradually with a complete washout period of two week.
• Chronicity of Vicharchika minimum 6 months to maximum 10 years.
• Patient Indicated for Vamana. |
|
| ExclusionCriteria |
| Details |
1.Patient unwilling to participate in the trial.
2.Patient having complication like Severe Renal disease, Severe hypertension,
Ischemic Heart Disease , Neuropathy, Dyslipidemia etc.
3.Age less than 18 years and more than 60 years.
4.Patient associated with any immunocompromised disease like AIDS, tuberculosis etc.
5.Patient having BMI index above 30.
6.Patient Contraindicated for Vamana as per Samhita. |
|
|
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 |
| Decrease in signs and symptoms. |
20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete relief in sign & symptoms. |
30th day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this part of study , literary review about disease Vicharchika will be collected from classical text of Ayurveda, thesis of previous research , scientific journals, periodical magazines, monographs and other available sources. Similarly modern review of the disease will be collected from modern medicine books and various website on internet and these will be properly compiled, analysed, classified and then will be presented in arranged manner. Patients will be randomly selected from OPD and IPD of Department of Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi.
The present study will be carried out in two groups, each group consisting of 30 patients.
Group A : In this group each patient will be subjected for Vamana Karma after Snehapana with Panchatikta Ghrita.
Follow up- 1st follow up on 20th day
2nd follow up on 30th day
Group B : In this group patients will be administered with Edgajadi Lepa locally for 30 days Dose : Atleast 10gm to be applied locally Once a day. Follow up - 1st follow up on 20th day - 2nd follow up on 30th day
Duration of study- 30 days |