FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104877 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing Yavadi cream and Yavadi herbal paste for the treatment of facial dark patches (melasma) in patients 
Scientific Title of Study   A Randomized Comparative Clinical Study to evaluate efficacy of Local application of Yavadi cream and Yavadi lepa in the Treatment of Vyanga w.s.r to Melasma 
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 PRIYANKA ARUN MHATRE 
Designation  PG SCHOLAR 
Affiliation  Padmashree Dr. D. Y. Patil Deemed to be University, School of Ayurveda 
Address  Dr. D. Y. Patil Deemed to be University, School of Ayurveda D. Y.Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul East, Navi Mumbai. Thane MAHARASHTRA 400706
Dr D.Y Patil Deemed to be University, School of Ayurveda D. Y. Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706
Thane
MAHARASHTRA
400706
India 
Phone  8329699939  
Fax    
Email  pri.mha.bams24@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  DR NEENA DAMLE 
Designation  Assistant Professor 
Affiliation  Padmashree Dr D.Y. Patil Deemed to be University, School of Ayurveda 
Address  D. Y. Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706 India
D. Y. Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706 India
Thane
MAHARASHTRA
400706
India 
Phone  9769028549  
Fax    
Email  neena.damle@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  DR NEENA DAMLE 
Designation  Assistant Professor 
Affiliation  Padmashree Dr D.Y. Patil Deemed to be University, School of Ayurveda 
Address  D. Y. Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706 India
D. Y. Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706 India
Thane
MAHARASHTRA
400706
India 
Phone  9769028549  
Fax    
Email  neena.damle@dypatil.edu  
 
Source of Monetary or Material Support  
Padmashree Dr. D. Y. Patil Deemed to be University, School of Ayurveda Sector 7, Nerul east, Navi Mumbai.  
 
Primary Sponsor  
Name  DR PRIYANKA ARUN MHATRE 
Address  Padmashree Dr. D. Y. Patil Deemed to be University, School of Ayurveda Sector 7, Nerul east, Navi Mumbai. 
Type of Sponsor  Other [[SELF]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Arun Mhatre   D.Y. Patil Ayurvedic Hospita  Padmashree Dr. D. Y. Patil Deemed to be University, School of Ayurveda 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706
Thane
MAHARASHTRA 		 832969939

pri.mha.bams24@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Padmashree Dr D.Y. Patil Deemed to be University, School of Ayurveda 1st floor, Kayachikitsa Department OPD No.1, Sector 7, Nerul east, Navi Mumbai. Thane MAHARASHTRA 400706  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yavadi cream , Reference: Chakradatta kshudraroga chikitsa 55/52, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: no
2Comparator ArmDrugClassical(1) Medicine Name: Yavadi lepa, Reference: Chakradatta kshudraroga chikitsa 55/52, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: NO
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects aged 30 to 60 years will be included.
2. Diagnosed cases of Vyanga (Melasma) based on classical and clinical criteria will be included.
3. Presence of facial hyperpigmented patches consistent with melasma will be included.
4. Both males and females will be included.
5. Subject is willing to participate and follow protocol will be included. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women will be excluded.
2. Other facial skin disorders (eg.lichen planus,post inflammatory hyperpigmentation) will be excluded.
3. Known Thyroid dysfunction case will be excluded.
4. Known Addisons disease will be excluded.
5. Recent use (within 3 months) of hormonal therapy, cosmetic procedures will be excluded. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in mMASI scoreimprovement in Taylor hyperpigmentation scale , dermoscopic changes, percentage improvement,.  0,10th,20th,30th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   24/03/2026 
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="6"
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  
This randomized comparative clinical study is planned to evaluate and compare the efficacy of Yavadi Cream and Yavadi Lepa in the management of Vyanga (Melasma). Vyanga is described in Ayurveda as a Raktapradoshaja and Kshudra Roga, characterized by painless, thin, bluish-black patches on the face, mainly caused due to Vata–Pitta vitiation triggered by factors like anger and mental stress. Although considered a minor disease in classics, Vyanga has major cosmetic and psychological impact in modern society.
In contemporary dermatology, melasma is commonly managed with topical agents, chemical peels, and lasers, which may cause adverse effects on prolonged use. Traditional lepa formulations, though effective, have limitations such as poor shelf life, inconvenience in preparation, and patient non-compliance. Hence, this study proposes a modified cream formulation of Yavadi Lepa to overcome these drawbacks and evaluates whether it offers comparable or superior efficacy.
A total of 120 subjects will be enrolled considering a 20% dropout rate, to obtain 50 completed subjects in each group. Subjects will be randomly allocated into two groups:
Group A: Yavadi Cream (local application)
Group B: Yavadi Lepa (local application)
Assessment will be carried out using both objective and subjective parameters. The primary assessment tool is the Modified Melasma Area and Severity Index (mMASI). Secondary assessment tools include the Taylor Hyperpigmentation Scale, dermoscopic evaluation, and standardized photographic documentation. Clinical response will be graded as excellent, good, moderate, or mild based on percentage improvement.
 
Close