| CTRI Number |
CTRI/2025/12/098851 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
use of arka tail and manshiladi lepa in eczema |
|
Scientific Title of Study
|
A Randomized Comparative Trial on the efficacy of Arka Tail and Manashiladi Lepa in the management of vicharchika (SN43) (eczema). |
| 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 Rameshwar lal |
| Designation |
PhD Scholar |
| Affiliation |
PGIA JODHPUR |
| Address |
PG Dept of Maulik Siddhant
PGIA JODHPUR
DSRRAU KARWAR JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460054984 |
| Fax |
|
| Email |
drdudi86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra singh chahar |
| Designation |
Professor |
| Affiliation |
PGIA JODHPUR |
| Address |
PG Dept of Maulik Siddhant
PGIA JODHPUR
DSRRAU KARWAR JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636981669 |
| Fax |
|
| Email |
vddschahar1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rameshwar lal |
| Designation |
PhD Scholar |
| Affiliation |
PGIA JODHPUR |
| Address |
PG Dept of Maulik Siddhant
PGIA JODHPUR
DSRRAU KARWAR JODHPUR
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460054984 |
| Fax |
|
| Email |
drdudi86@gmail.com |
|
|
Source of Monetary or Material Support
|
| DSRRAU JODHPUR
KARWAR NAGOUR ROAD JODHPUR
342037 |
|
|
Primary Sponsor
|
| Name |
DSRRAU JODHPUR |
| Address |
DSRRAU JODHPUR
KARWAR NAGOUR ROAD JODHPUR
342037 |
| 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 Rameshwar lal |
Sanjeevani hospital |
OPD No.10, Sanjeevani hospital, Dr Sarvapalli Radhakrishnana Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN |
9460054984
drdudi86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DRSRAU JODHPUR PGIA |
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: Arka taila, Reference: YogratanakarKustha Nidan Chikitsa Prakaran203, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Arka taila will be applied on affected area | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manahshiladi Lepa, Reference: Charaka Su.3/12, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Manashiladi lepa will be applied on the affected area |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Diagnosed Patient of vicharchika according to subjective perameter of samhitas has complaints of itching, Burning sensation,discharge, dryness, eruption, and depigmentation |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from disorders like diabetes Mellitus, systemic infections.
2. Age- below 12 years and above 60 years.
3. patients who are suffering from major psychiatric disorders.
4. Patients suffering from major systemic illnesses like myocardial infraction, Ischemic heart disease, AIDS, Cancer, Major respiratory disease, liver failure, Renal failure and Renal toxicity etc.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any changes in EASI score |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Arka Tail and Manashiladi Lepa will provide a safe and effective treatment and improve the quality of life |
90 days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
It is a randomized, prospective, open- label, interventional comparative clinical trial. the trial consist of two groups: one group will recieve Arka taila as external application. Other group will recieve Manahshiladi lepa as external application. At the end of the study both groups will be compared for results. |