| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L818||Other specified disorders of pigmentation. Ayurveda Condition: KARSHNYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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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