| CTRI Number |
CTRI/2025/11/096835 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Aragwadhadi Lepa in Vicharchika |
|
Scientific Title of Study
|
Role of Aragwadhadi lepa in vicharchika |
| 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 Sanjay kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Dr Sanjay kumar Tripathi |
| Address |
OPD no. 1 Dept. of Kayachikitsa ,Rishikul Campus Uttarakhand Ayurved University, Hariwar, Uttarakhand 249401, India
OPD no. 1 Dept. of Kayachikitsa ,Rishikul Campus Uttarakhand Ayurved University, Hariwar, Uttarakhand 249401, India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
Sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Dr Sanjay kumar Tripathi |
| Address |
OPD no. 1 Dept. of Kayachikitsa ,Rishikul Campus Uttarakhand Ayurved University, Hariwar, Uttarakhand 249401, India
OPD no. 1 Dept. of Kayachikitsa ,Rishikul Campus Uttarakhand Ayurved University, Hariwar, Uttarakhand 249401, India
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 |
Dr Sanjay kumar Tripathi |
| Address |
OPD no. 1 Dept. of Kayachikitsa ,Rishikul Campus Uttarakhand Ayurved University, Hariwar, Uttarakhand 249401, India
OPD no. 1 Dept. of Kayachikitsa ,Rishikul Campus Uttarakhand Ayurved University, Hariwar, Uttarakhand 249401, India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
Sanjaytripathi.230@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.1 Dept. Of Kayachikitsa, Rishikul Campus, Uttarakhand Ayurved University,Haridwar, Uttarakhand 249401 India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University Dehradun |
| Address |
Uttarakhand Ayurved University Haridwar, Uttarakhand 249401 India |
| 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 Aisha Vishwakarma |
Rishikul Campus,Haridwar,Uttarakhand Ayurved University |
OPD NO.1 P.G.Department of Kayachikitsa,Uttarakhand ayurved university(Dehradun)249401
Hardwar
UTTARANCHAL |
8126284485
aishavishwakarma99@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: Aragwadhadi lepa, Reference: Charaka samhita Sutra sthana chapter 3 Shloka no 17, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Vicharchika as per subjective criteria
Chronicity less than 5 year
Age group between 20 to 60 year
Patient willing to participate in above mentioned trial with informed consent |
|
| ExclusionCriteria |
| Details |
Age group less than 20 year and more than 60 year
Patient with other cutaneous symptoms of Psoriasis Leprosy Local burn etc
Any other secondary skin disease
Chronicity more than 5 year
Uncontrolled Diabetic |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kandu(Itching)
Vedana(Pain)
Daha(Burning sensation)
Vivarnata(Discolouration)
Rukshta(Dryness) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of lesion
Area occupied by the lesion |
15 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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
|
Skin disease are a major health problem affecting a high proportion of the population. Vicharchika is correlated with eczema in modern science.Modern science has no specific medication for cure of eczema but symptomatic treatment like steriods are used which is not safe and also produce side effects.A whole world is looking toward Ayurveda for it.Aragwadhadi lepa is a a very cost effective drug for the patients and is accessible to the patients. |