| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingival hyperpigmentation |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
melanoma cell lines |
|
| ExclusionCriteria |
|
|
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 |