| CTRI Number |
CTRI/2025/03/083214 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of masooradi lepa on mukhdushika |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Effect Of Masooradi Lepa In Mukhdushika With Special Referance To Acne Vulgaris |
| 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 Swati Harendra Rahangdale |
| Designation |
PG Scholar Swasthvritta |
| Affiliation |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and
Hospital, Post Graduate and Institute and Reseach centre,Islampur,
Tal - Walwa Dist Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9075104841 |
| Fax |
|
| Email |
swatirahangdale.cm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Nakil |
| Designation |
Professor |
| Affiliation |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no 1 Lokanete Rajarambapu Patil Ayurved Medical College and
Hospital Post Graduate and Institute and Reseach centre Islampur
Tal Walwa Dist Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9850920891 |
| Fax |
|
| Email |
shwetanakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Harendra Rahangdale |
| Designation |
PG Scholar Swasthvritta |
| Affiliation |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and
Hospital, Post Graduate and Institute and Reseach centre,Islampur,
Tal - Walwa Dist Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9075104841 |
| Fax |
|
| Email |
swatirahangdale.cm@gmail.com |
|
|
Source of Monetary or Material Support
|
| opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and
Hospital, Post Graduate and Institute and Reseach centre,Islampur,
Tal - Walwa Dist Sangli 415409 |
|
|
Primary Sponsor
|
| Name |
LRP Ayurved Medical College and Hospital, Post Graduate and Institute and Reseach centre,Islampur |
| Address |
opd no. 1 Lokanete Rajarambapu Patil Ayurved Medical College and
Hospital, Post Graduate and Institute and Reseach centre,Islampur,
Tal - Walwa Dist Sangli 415409 |
| Type of Sponsor |
Private 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 Swati Harendra Rahangdale |
LRP Ayurveda Hospital, Islampur |
opd no.1 Lokanete
Rajarambapu Patil
Ayurved Medical
College and Hospital,
Post Graduate and
Institute and Reseach
centre,Islampur, Tal -
Walwa Dist Sangli
415409
Sangli
MAHARASHTRA |
9075104841
swatirahangdale.cm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LOKNETE RAJARAMBAPU PATIL A YURVEDIC MEDICAL COLLEGE, HOSPITAL, POST GRADUATE INSTITUTE AND RESEARCH CENTER, ISLAMPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Angadi Ravindra, Text book of Bhaishajya kalpana vijnana, 2d edition, Varanasi, Chaukhamba Surbharti prakashan 2016, Procedure details: The selected freshly dried drugs are taken in a clean Khalva yantra, pounded to fine powder form & filtered. This filtrate is again taken in Khalva yantra and added with required little quantity of water or any of the specified liquid preparations. The mixture is thoroughly triturated to obtain it in paste)
(1) Medicine Name: Lodradi Choorna, Reference: Susrut samhita chikitsasthan 20/37, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Duration: 1 Weeks | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Shri Bramhanand shastri, yogratnakar uttarardh, chaukhamba shanshkrit sansthan varanashi, Edition 8, 2014, slock14, chapter 40, page 283, Procedure details: Take choorna of Masoordal & add milk to form paste & then add ghrit to apply lepa on face. It will be prescribed for 7 days after which face will become clean just like a Kamal Patra)
(1) Medicine Name: Masooradi Choorna, Reference: Yog Ratnakar 40/14, Route: Topical, Dosage Form: Lepa Churna, Dose: 18(g), Frequency: od, Duration: 1 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having symtomsof Mukhdushika will be included.
Individuals between age group of 12 to 30 Years Will be included.
Individuals will be selected of both sexes irrespective of
Socioeconomic Status. Patients who reported mild-to-moderate inflamed acne with lesion size
1 cm.
Reliable and cooperative patients able to followall study procedures
|
|
| ExclusionCriteria |
| Details |
Individuals suffering from skin disorders other than
Mukhdushika.
Individuals suffering from any other systemic diseases will be excluded.Individuas prone to allergic reaction.Individual taking long term medication like oral contraceptive pills will be excluded.
Patients using facial topical medicine or receiving
any hormone therapy. Patients who have any facial skin disease (apart from acne vulgaris) such as psoriasis or eczema that may interfere with the study procedures.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Masooradi Lepa is Effective on Mukhdushika |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lodhradi Lepa is Effective on Mukhdushika |
15 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/04/2025 |
| 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
|
Regardless of wide research , detail understanding and treatment modalities it still remains to be
cause of concern due to its recurrent nature. In this study of Randomised clinical trial of Masooradi Lepa on Mukhdushika with special reference to Lodhradi lepa . 60 patient will be
taken divided by 2 equal groups .One group will be given Masooradi Lepa while other will be
given Lodhradi and further research will be concluded.
|