| CTRI Number |
CTRI/2025/05/086374 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MANAGEMENT OF DUSHIVISHJANYA VICHARCHIKA through VISHA TAILA AND
SIKTHADI TAILA ALONG WITH ORAL ADMINISTRATION OF BAKUCHI
CHURNA |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY ON EFFICACY OF VISHA TAILA AND
SIKTHADI TAILA ALONG WITH ORAL ADMINISTRATION OF BAKUCHI
CHURNA IN THE MANAGEMENT OF DUSHIVISHJANYA 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 Archana Sharma |
| Designation |
M.D. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7014479745 |
| Fax |
|
| Email |
archana208sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pappu Lal Sharma |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9783023473 |
| Fax |
|
| Email |
drpappulal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pappu Lal Sharma |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
RAJASTHAN
313001
India |
| Phone |
9783023473 |
| Fax |
|
| Email |
drpappulal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan 313001 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 Archana Sharma |
rajkiya ayurved Chikitshalya Moti Chohtta Udaipur rajasthan 313001 |
agad tantra vibhaga room No 23
Udaipur
RAJASTHAN |
7014479745
archana208sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee MMM Government ayurved college udaipur rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bakuchi Churna, Reference: Bhaishjayratnawali 57/54, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Visha taila, Reference: Chikitsaarnav KUSTHAROGADHIKAR, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Sikhtadi taila, Reference: A.H. Chi. 19/84, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the classical signs and symptoms of Vicharchika,
Patient of either sex aged between 18-50years.
Patient willing for the treatment and should be given Consent form
Patient having family history of Vicharchika |
|
| ExclusionCriteria |
| Details |
The patient suffering from any other skin disease or severe systemic illness.
Like- Psoriasis, Leprosy,etc.
Taking any other Medication for the same illness..
The pregnant women and lactating mother will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in classical signs and symptoms of dushivishjanya Vicharchika |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the EASI score of Eczema before and after Intervention |
45 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/05/2025 |
| 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="0"
Months="1"
Days="15" |
|
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
|
This is a clinical trial to compare the efficacy of VISHA TAILA topical application 3ml in Group A AND
SIKTHADI TAILA topical application 3ml in Group B ALONG WITH ORAL ADMINISTRATION OF BAKUCHI
CHURNA 3 gm orally in both group A and Group B IN THE MANAGEMENT OF DUSHIVISHJANYA VICHARCHIKA |