| CTRI Number |
CTRI/2025/03/082885 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| 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 DUSHIVISHAJANYA VYANGA through VARNAKA GHRITA AND VARNYA MAHAKASHAYA ALONG WITH ORAL ADMINISTRATION OF SHIRISH CHURNA |
|
Scientific Title of Study
|
EFFICACY OF EXTERNAL APPLICATION OF VARNAKA GHRITA AND VARNYA MAHAKASHAYA ALONG WITH ORAL ADMINISTRATION OF SHIRISH CHURNA IN DUSHIVISHAJANYA VYANGA WITH SPECIAL REFERENCE TO MELASMA |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramprasad Meena |
| Designation |
MD Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8384953498 |
| Fax |
|
| Email |
drramprasadmeena946@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
Rajasthan
313001
india
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9783023473 |
| Fax |
|
| Email |
pappulalsharma@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
Rajasthan
313001
india
PG Department of Agad Tantra Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9783023473 |
| Fax |
|
| Email |
pappulalsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya government ayurved college udaipur rajasthan 313001 India |
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya government ayurved college udaipur |
| Address |
Madan mohan malviya government ayurved college udaipur rajasthan 313001 |
| 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 Ramprasad Meena |
Rajkiya Ayurved Mahavidhyalaya Chikitsalya Moti Chohtta Udaipur |
OPD No 23 Rajkiya Ayurved Mahavidhyalaya Chikitsalya Moti Chohtta Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN |
08384953498
drramprasadmeena946@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Healthy Human Volunteers |
60 |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirish churna, Reference: dhanwantri nighantu 102-103, 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: Varnaka ghrita, Reference: chakradutta 55/77-78, Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Varnya mahakashaya, Reference: charak sutrasthan 4/8, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, 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 |
Patients with classical sign and symptoms of dushivishajany vyanga.
Patients from the age group of 18 to 50 years of either sex.
|
|
| ExclusionCriteria |
| Details |
•Hyperpigmentation since birth like Nevus of Ota
•Age less than 18 years and more than 50 years
•Dushivishajanya vyanga (melasma) caused due to any systemic disease like Addison’s disease, Cushing’s syndrome etc.
•Patients having skin disease like – psoriasis, leprosy, acne vulgaris, eczema and leucoderma.
•hyperpigmentation due to tubercular therapy or malignant cases.
•Dushivishajanya vyanga (melasma) caused by tumor like malignant melanoma.
•History of hypersensitivity.
•Pregnant and lactating women.
|
|
|
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 the clinical manifestations of dushivishajanya vyanga |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in objective parameters of melasma & QOL (quality of life) of patients |
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)
|
10/04/2025 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a clinical trial to compare the efficacy of external application of Varnaka ghrita 2 gm in group A and Varnya mahakashaya 3 gm in group B along with oral administration of Shirish churna 3 gm in both group A and group B in the management of dushivishajanya vyanga with special reference to Melasma
|