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CTRI Number  CTRI/2025/03/083112 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Invitro study 
Study Design  Other 
Public Title of Study   Invitro study for evaluation of herbal dressing 
Scientific Title of Study   Formulation and evaluation of periodontal dressing containing vitamin c and banana peel extract and its effectiveness on melanocytes an invitro study 
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 Surekha Rathod 
Designation  Professor 
Affiliation  Ranjeet Deshmukh Dental College, Nagpur 
Address  104,Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre

Nagpur
MAHARASHTRA
440019
India 
Phone  09011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surekha Rathod 
Designation  Professor 
Affiliation  Ranjeet Deshmukh Dental College, Nagpur 
Address  104, Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre

Nagpur
MAHARASHTRA
440019
India 
Phone  09011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surekha Rathod 
Designation  Professor 
Affiliation  Ranjeet Deshmukh Dental College, Nagpur 
Address  104, Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre

Nagpur
MAHARASHTRA
440019
India 
Phone  09011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Source of Monetary or Material Support  
sellf 
 
Primary Sponsor  
Name  self 
Address  Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre 
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 Surekha Rathod  Ranjeet deshmukh dental college  Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA 
09011071477

drsurekhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ranjeet Deshmukh Dental College ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  gingival hyperpigmentation 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  melanoma cell lines  
 
ExclusionCriteria 
Details  other cell lines 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MTT Assay, melanin content assay  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
bradford assay  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   08/07/2025 
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="0"
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  

A number of studies using herbal extracts with antioxidant property shown to have anti melanogenic effect. Studies have shown that the use of cinnamon, ascorbic acid, curcumin, exhibiting anti oxidant properties helped in the scavenging of reactive oxygen inhibiting the melanin formation by preventing reduction of the dopamine. Studies also reported that sucrier banana peel extracts, could inhibit melanogenesis through the ERK signaling pathway. [4] Ascorbic acid/Vitamin C has been introduced as treatment of melanin pigmentation due to its suppressing effect on the tyrosine activity which directly downregulates dopaquinone formation, a precursor in melanin synthesis, as well as its epigenetic inhibitory effect on genes responsible for melanocytes function. However, to date, to the best of our knowledge, there has been paucity of literature on effect of combination of vitamin C and banana peel dressing on melanocytes

 
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