| CTRI Number |
CTRI/2023/07/055857 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study of eczema by skin examination using dermatoscopy. |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY OF TWAKA PAREEKSHANA IN VICHARCHIKA WITH THE HELP OF DERMATOSCOPY |
| 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 Siddhant Jain |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
PG and PhD Department of Roga Nidana Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9893854648 |
| Fax |
|
| Email |
siddhantsona.jain.1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep G Dahilekar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
PG and PhD Department of Roga Nidana Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9420090584 |
| Fax |
|
| Email |
sandeep.dahilekar260086@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep G Dahilekar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
PG and PhD Department of Roga Nidana Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9420090584 |
| Fax |
|
| Email |
sandeep.dahilekar260086@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved, Parul University, Limda, Vadodara, Gujarat - 391760, India |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
PG and PhD Department of Roga Nidana Evum Vikriti Vigyan, Parul Institute of Ayurved, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat. |
| 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 Siddhant Jain |
Parul Ayurved Hospital, Khemdas Ayurved Hospital, Parul Sevashram Hospital |
OPD No. 116 & 08 (Kayachikitsa) OPD No. 105 & 07 (Panchkarma) OPD No. 16 (Skin PSH) IPD No. 201,203,205,301 & 302 (Kayachikitsa & Panchkarma) Parul University, P.O.-Limda Tal- Waghodia Vadodara Gujarat
Vadodara
GUJARAT |
9893854648
siddhantsona.jain.1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PARUL INSTITUTE OF AYURVED, PARUL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Selection of patients will be done irrespective of gender, socioeconomic status.
2. The diagnosed patients with Lakshanas of Vicharchika between the age of 18-60 years will be included for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient with local Skin infections and congenital anomalies will be excluded.
2. Patient having major ailments of other systems.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
As this is an Observational study & I am going
to assess the changes on skin due to vicharchika.
There may be some changes which I will get or
there may be nothing significant findings.Here
we are going to assess the Discoloration,
Papular eruption, Discharge of skin in diagnosed
patients of vicharchika. |
18 Months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
As this is an observational study & i am going
to assess the changes on twak due to vicharchika.
There may be some changes which I will get or
there may be nothing significant findings. Here
we are going to assess the Discoloration on twak,
Papular eruption on twak , Discharge of twak in diagnosed
patients of vicharchika. |
18 Months. |
|
|
Target Sample Size
|
Total Sample Size="185"
Sample Size from India="185"
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)
|
31/07/2023 |
| 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)
|
Not Applicable |
| 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
|
• VICHARCHIKA (Eczema) is a type of Kshudrakustha often encountered by Ayurvedic Dermatologists characterized by symptoms, namely, kandu (itching), srava (discharge), Pidaka (vesicles), and Shyava varna (discoloration). Vicharchika is often correlated to eczema based on clinical presentations. No satisfactory treatment is available in contemporary medical practice except antihistamines and topical steroids. The main line of treatment for Vicharchika in Ayurveda is Shodhana and shaman Aushadhis. · As Skin diseases are occurring in the early phase of life due to various etiological factors so to establish which type of doshika Twaka roga is dominant, and to find investigation changes in different types of Twaka roga so we can get early prevention, management, and awareness regarding a particular type of doshika Twaka roga, especially Vicharchika.
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