| CTRI Number |
CTRI/2022/07/044392 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
26/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic approach for skin disorder |
|
Scientific Title of Study
|
Role of Vicharchikari Tail and Laghu Manjisthadi Kwath in Vicharchika |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Kumari |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
PG Department of Kayachikitsa Rishikul Campus Uttarakhand
Ayurveda University Haridwar
PG Department of Kayachikitsa
Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6397137909 |
| Fax |
|
| Email |
asha45041@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Uttrakhand Ayurveda University Rishikul Campus |
| Address |
PG Department of Kayachikitsa Rishikul Campus Uttrakhand Ayurveda University Haridwar
PG Department of Kayachikitsa
Rishikul Campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Uttrakhand Ayurveda University Rishikul Campus |
| Address |
PG Department of Kayachikitsa Rishikul Campus Uttrakhand Ayurveda University Haridwar
PG Department of Kayachiktsa
Rishikul campus Uttarakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.230@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Asha kumari
PG Department of Kayachikitsa
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
|
|
Primary Sponsor
|
| Name |
Dr Asha Kumari |
| Address |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar 249401 |
| 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 |
| Asha Kumari |
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
P.G Department of Kayachikitsa Rishikul Campus Uttarakhand Ayurveda University Haridwar 249401
Hardwar
UTTARANCHAL |
6397137909
asha45041@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vickarchikari Tail and Laghu Manjisthadi Kwath, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Vicharchikari Tail
Local Application
BID for 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having the signs & symptoms of Vicharchika.
2.Patient willing to participate in above mentioned trial with informed consent. |
|
| ExclusionCriteria |
| Details |
1.Age group less than 20 years and more than 60 years
2.Pregnancy and lactations.
3.Patients known case of Psoriasis, leprosy, local burn etc.
4.Any other secondary skin disease.
5.Uncontrolled Diabetic & Hypertension patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of sign and symptoms of Eczema such as Itching, Pain, Burning Sensations, Redness, Discharge. |
2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in CBC ESR |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In Ayurvedic texts, all skin diseases were included under the term ’Kushtharoga’ which is classified into two main divisions i.e., Mahakushtha and Kshudrakushtha. Vicharchika is a type of kshudra kushtha often encountered by Ayurvedic dermatologists characterised with symptoms namely Kandu, Srava, Pidika. The clinical presentations of Vicharchika is similar to eczema in modern dermatology. Eczema also called atopic dermatitis is characterized by dry itchy skin with the areas of poorly demercated erythema and scale. In the acute phase eczema may be vesicular and oozing, in the chronic phase it may become hyper pigmented and lichenified (thickened). Excoriations (scratch marks) are frequently seen. |