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CTRI Number  CTRI/2025/07/091196 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Development of Ayurvedic cream for dark circles. 
Scientific Title of Study   Evaluation of varnya effect of varnya mahakashaya cream in periorbital melanosis: open label clinical trial 
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 Sarika Mahesh Bhujbal 
Designation  Practitioner 
Affiliation  Bharati Vidyapeeth Deemed to Be University College of Ayurveda 
Address  Ayurveda Samhita and Siddhant Department, Third floor, Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi,Pune
Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9970570526  
Fax    
Email  vdsarikam@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarika Mahesh Bhujbal 
Designation  Practitioner 
Affiliation  Bharati Vidyapeeth Deemed to Be University College of Ayurveda 
Address  Ayurveda Samhita Siddhanta department, Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi Pune
Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9970570526  
Fax    
Email  vdsarikam@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sarika Mahesh Bhujbal 
Designation  Practitioner 
Affiliation  Bharati Vidyapeeth Deemed to Be University College of Ayurveda 
Address  Ayurved Samhita and Siddhant Department, Third floor, Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi Pune
Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9970570526  
Fax    
Email  vdsarikam@yahoo.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi Pune 411043  
 
Primary Sponsor  
Name  Bharati Ayurveda Hospital will support infrastructurally to conduct clinical trial 
Address  Bharati Vidyapeeth Deemed to Be University College of Ayurveda Dhanakawadi,Pune- 411043 
Type of Sponsor  Research institution and hospital 
 
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 Sarika Mahesh Bhujbal  Ayurveda Hospital Bharati Vidyapeeth,Dhanakawadi,PUNE 411043  Room No. 40, OPD of Kaya Chikitsa Dept.
Pune
MAHARASHTRA 
9970570526

vdsarikam@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth deemed to be University college of ayurveda ethics comitee (BVDUCOA-EC)  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: KARSHNYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Varnya Mahakashaya cream, Reference: Charak Samhita Sutrasthan 4/8, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.50(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Varnya Mahakashaya will be converted into cream by using Varnya Mahakashaya Ghrit and natural substances and it will be used topically.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects of Periorbital Melanosis diagnosed since last one year
Age group between 18 to 40 years irrespective of their gender, religion and socioeconomic status

 
 
ExclusionCriteria 
Details  Subjects using another topical application or Internal Medication for Skin complexion
enhancement
Malignant melanoma
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs of Periorbital Melanosis.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/08/2525 
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)?  

Brief Summary  

                                        Periorbital Melanosis  is a darkening of the skin caused by an increase in production of or distribution of melanin, it involves the lower eyelid sometimes extending to the upper eyelid. It is a cosmetic concern for a large number of individuals who relate it with significant impairment on quality of life. Despite of it being common, there are not much or very few studies published on Periorbital Melanosis. There are several treatment options available but there is a lack of evidence - based study. The use of topical depigmenting agents is the most widely reported method in the clinical management of POM. Periorbital Melanosis i.e.Akshikut Karshnya comes under the broad umbrella of features of aggravation of Vata and Pitta like Vaivarnya , blackish discoloration i.e.Karshnya, Dark coloration i.e.Shyavata which can also be categorized under disease predominant in Vata . Acharya Charaka has mentioned Varnyadashemani - a group of ten herbs for the enhancement of Varna. Chandana i.e. Santalum album, Tunga i.e. Mesua ferrea, Padmaka i.e. Prunus cyrasodius, Ushira i.e. Vetiveria zizaniodis, Madhuka i.e. Glycyrrhiza glabra, Manjishtha i.e. Rubia cordifolia, Sariva i.e. Hemidesmus indicus, Payasya i.e. Ipomoia digitata, Sita i.e.Cynodon dactylon, Lata i.e.Cynodon dactylon. Varnya Mahakashaya is useful in internal i.e.Antaparimarjan chikitsa as well as external i.e. Bahiparimarjan chikitsa or treatment.

Detailed study of mode of action of all these dravyas will enlighten the different treatment modalities.

Extensive literature study of Varna and Varnya effect from Various Samhita is not done yet. Varnya Mahakashaya cream (VMC) in Periorbital  Melanosis is not explored yet. Hence, it’s a need to transform the Varnya Mahakashaya ingredients into modified dosage form by developing Standard quality Varnya Mahakashaya cream. Varnya Mahakashaya decoction with its medicated Ghrit will be used for developing VMC, which will act on Bhrajak Pitta and Rakta dhatu to enhance skin complexion in POM. This research is an attempt to carry out a randomized, open label, single arm study to evaluate Varnya effect of Varnya Mahakashaya Cream  in Periorbital Melanosis .    

                                          

 
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