| CTRI Number |
CTRI/2026/03/106442 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Seasonal Herbal Face Application Sharad Ritu Mukhalepa in the Management of Facial Skin Disorders |
|
Scientific Title of Study
|
An exploratory study to evaluate the effect of sharad ritu mukhalepa in the management of mukhgat twak vikaras in pitta prakriti purusha |
| 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 Anita Yadav |
| Designation |
MD Scholer |
| Affiliation |
PGIA DSRRAU JODHPUR |
| Address |
Room 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Research and Studies Dr Sarvepalli Radhakrishnan Rajasthan Aurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7062159735 |
| Fax |
|
| Email |
anyyadav9166@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bramhmanand sharma |
| Designation |
Associate Professor and Hod |
| Affiliation |
PGIA DSRRAU JODHPUR |
| Address |
Room 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Research and Studies Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bramhmanand sharma |
| Designation |
Associate Professor and Hod |
| Affiliation |
PGIA DSRRAU JODHPUR |
| Address |
Room 111 PG Department of Swasthavritta and Yoga Post Graduate Institute of Ayurveda Research and Studies Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur 342037 India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
Post Graduate Institute of Ayurveda Research AND Studies Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan |
| 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 ANITA YADAV |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
PG Department of Swasthavritta and Yoga Post Graduate Institute Of Ayurveda Research and Studies Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
7062159735
annyyadav9166@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIA DSRRAU JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sharad Ritu Mukhalepa, Reference: Asthang hridaya Sutrasthan 22, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis and confirmed cases of Mukhgat Twak Vikaras in Pitta Prakriti Purush as per the screening of Prakriti and sign and symptoms
Patients between the age group of 16 -50 years of irrespective gender, religion, occupation
Patients willing to give written consent
|
|
| ExclusionCriteria |
| Details |
Patients of age below 16 years & above 50years of either sex
Malignant cases of mukhgat twak vikaras
Patients unfit for Lepa like Pinus Ajirna Hanugrah
Patients with side-effects of other medications like Steroids
Patients having domminant vatta and domminant kapha prakriti
Chronic systematic diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the therapeutic and preventive effect of Sharad Ritu mukhalepa in the management of Mukhgat Twak vikaras in the Pitta Parkriti Purush |
60 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in subjective and objective parameters |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
14/04/2026 |
| 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)
|
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
|
1 NO OF PATIENTS 40 2 AGE OF PATIENTS 16 TO 50 Year 3 Name of Drug Sharad Ritu Mukhalepa 4 Duration of Trail 2 month 5 Route Topically application 6 Type of study Single arm open labelled study 7 Follow up after 7 days
|