| CTRI Number |
CTRI/2025/04/085809 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Lepa] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of application of Arjunadi Lepa in treatment of vaang (melasma)_black patches over face . |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO ASSESS THE ROLE OF ARJUNDI LEPA IN MANAGEMENT OF VYANGA IN ADULTS |
| 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 Shraddha Dnyaneshwarrao Yadgire |
| Designation |
PG scholar |
| Affiliation |
Vidarbha Ayurveda Mahavidyalaya Amaravai. |
| Address |
OPD no.9, Kayachikitsa Department, Vidarbha Ayurveda Mahavidyalaya And GNT hospital Dhanwantari Nagar,Amravati.
OPD no.9, Kaychikitsa Department Vidarbha Ayurveda Mahavidyalaya And GNT hospital Dhanwantari Nagar,Amaravai.
Amravati
MAHARASHTRA
444605
India |
| Phone |
9309804569 |
| Fax |
|
| Email |
shraddhakakade108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali H Wankhade |
| Designation |
Guide And HOD kaychitsa department |
| Affiliation |
Vidarbha Ayurveda Mahavidyalaya, Amravati |
| Address |
OPD no.9, Kayachikitsa department, Vidarbha Ayurveda Mahavidyalaya, Dhanwantari Nagar Amravati.
Parijat colony, Badnera road, Amravati.
Amravati
MAHARASHTRA
444605
India |
| Phone |
9420125432 |
| Fax |
|
| Email |
vaishalivhww@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Dnyaneshwarrao Yadgire |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurveda Mahavidyalaya Amravati. |
| Address |
OPD no.9, Kayachikitsa Department, Vidarbha Ayurveda Mahavidyalaya And GNT hospital Dhanwantari Nagar,Amravati.
OPD no.9, Kayachikitsa Department, Vidarbha Ayurveda Mahavidyalaya And GNT hospital Dhanwantari Nagar,Amravati.
Amravati
MAHARASHTRA
444605
India |
| Phone |
9309804569 |
| Fax |
|
| Email |
shraddhakakade108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurveda Mahavidyalaya Amravati ,444606 |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurveda Mahavidyalaya Amravati |
| Address |
Vidarbha Ayurveda Mahavidyalaya, Dhanwantri Nagar, Amravati 444606 |
| 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 |
| Dr Shraddha Dnyaneshwarrao Yadgire |
Vidarbha Ayurveda Mahavidyalaya Amravati |
OPD no.9, Kaychikitsa Department And GNT hospital Dhanwantari Nagar Amravati.
Amravati
MAHARASHTRA |
9309804569
shraddhakakade108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Vidarbha Ayurveda Mahavidyalaya, Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L550||Sunburn of first degree. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushrut samhita , Procedure details: Arjunadilep is explained in Yog ratnakar Kshudrarog chikitsa.
Raw material will be taken from authentic drug distributor raw drug authentication will be done. lepa will be prepared as mentioned by Yogratnakar
Materials used for lepa: Arjun twak, Manjishtha twak, Vasa patra powder
taken in equal proportion and mixed with honey
Lepa procedure
Purvakarma - Wash the face with clean water.
Pradhan karma - Apply lepa on affected part of face (of vyanga).
Pashchat karma - Remove it after 20 minutes or before it get dry.
Melazma on face wll be recorded with digital camera so that slight change in complexion could be noted for duration of 60 days follow after 10,20,30,40,50,60.)
(1) Medicine Name: Arjunadi lepa , Reference: Yog ratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient of vyanga with Chronicity less than 5 years.
Patient of vyanga having symptoms of Shyava Varna yukta, Niruja, Tanu Mandalas present the face. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 50 years.
Vyanga caused due to any systematic diseases like Addisons diseases, Cushings syndrome, systemic lupus erythematous.
Vyanga caused since birth like nevus of ota etc.
Vyanga caused by like malignant melanoma.
Inflammatory pigmentation.
Acne vulgaris.
Patient having abnormality regarding CT, BT and Diabetes.
Having viral infection like herpes.
Pregnant and lactating mothers.
Any history or hyper sensitivity to cream or lot. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Niruj, Tanu, Shyava mukh pradeshi vaivarya is completely resolved. |
Niruj, Tanu, Shyava mukh pradeshi vaivarya is completely resolved in 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from all kinds of symptoms.
Clear skin achieved. |
30th day
40th day
50th day
60th day |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
12/05/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A single arm clinical study to assess the role of Arjunadi Lepa in management of vyanga in adults.
-Trial will be conducted in our institute.
Total 35 patient diagnosed with classical sign and symptoms of vyanga will be selected
Arjunadi lepa will be given to the selected patient .The study will be conducted for 6o days.
Result will be compared before and after treatment.
Data analysis will be done by using appropriate statistical test.
Primary outcomes will be to study the effectiveness of Arjunadi lepa In Vyanga and complete,moderate and mild exeption of vyanga in patients. |