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CTRI Number  CTRI/2025/02/080439 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 21/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intervention of Manjishthadi Tail abhyanga for reducing melasma 
Scientific Title of Study   Preparation, standardization and exploratory comparative clinical study of Manjishthadi Tail abhyanga with and without Udvartan in patients of Melasma (Vyanga). 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Drpragati Toraskar 
Designation  MD Scholar 
Affiliation  BVDU College of Ayurved and hospital,Bharati Vidyapeeth (Deemed to be) University,Pune 411043 
Address  BVDU College of Ayurved and hospital Bharati Vidyapeeth (Deemed to be) University Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  9309312620  
Fax    
Email  pragatitoraskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Drpragati Toraskar 
Designation  MD Scholar 
Affiliation  BVDU College of Ayurved and hospital,Bharati Vidyapeeth (Deemed to be) University,Pune 411043 
Address  BVDU College of Ayurved and hospital Bharati Vidyapeeth (Deemed to be) University Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  9309312620  
Fax    
Email  pragatitoraskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Drpragati Toraskar 
Designation  MD Scholar 
Affiliation  BVDU College of Ayurved and hospital,Bharati Vidyapeeth (Deemed to be) University,Pune 411043 
Address  BVDU College of Ayurved and hospital Bharati Vidyapeeth (Deemed to be) University Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  9309312620  
Fax    
Email  pragatitoraskar@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed to be University Ayurved Hopsital, OPD of Kayachikitsa, Pune 43 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Trupti Patil   Bharati Vidyapeeth Deemed to be University, College of Ayurved and hospital Pune   Department of Kayachikitsa OPD OPD number 4 Bharati Vidyapeeth Deemed to be University College of Ayurved and Ayurved Hospital Pune 411043
Pune
MAHARASHTRA 		 02040555600

truptibhole@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L818||Other specified disorders of pigmentation. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Manjishthadi Taila application followed by Gram Flour with coffee scrub , Reference: Chakradatta Kshudraroga chikitsa verse number 56-61, chapter number 55 for gramflour-Rajnighantu,chapter-16/84-85, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: application of medicated oil followed by udvartan that is Ayurvedic scrub
2Intervention ArmDrugClassical(1) Medicine Name: Manjishthadi Taila , Reference: Chakradatta Kshudraroga chikitsa verse number 56-61, chapter number 55 , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: nil
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Chronicity less than 2 years
2.Patients having signs and symptoms of melasma [vyanga] ie like Shavavarnayukta, Niruja Mandalas present over the face .
3.Either sex.
4. All economic strata and prakriti 
 
ExclusionCriteria 
Details  Inflamation pigmentation.
2.
Malignant melanoma.
3.
Acne vulgaris 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of the patient will be done on 7th day after intervention for 7 days.  Assessment of the patient will be done on 7th day after intervention for 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil  
 
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 
Date of First Enrollment (India)   25/02/2025 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   In this study Manjishthadi Tail will be pepared using granthokta formula with coconut oil. In text there is no specification, however considering the fact that coconut oil is sheeta virya and non -irritating it is well tolerated, and non allergic. Hence for cosmetic use it is used. Udvartan churna will be prepared , using Gram flour and coffee. its an attempt to use coffee with the Gram flour for scrubing which helps to exfoliate the dead skin and having a property of skin brightening.There is no reported clinical study of this formula for vyanga and for skin complexion. 
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