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CTRI Number  CTRI/2021/04/032895 [Registered on: 16/04/2021] Trial Registered Retrospectively
Last Modified On: 20/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing The Effect Of Herbal Extract With Gold Standard Drug For Treatment Of Homogenous Leukoplakia  
Scientific Title of Study   Comparison of effectiveness of Calendula officinalis extract with Lycopene gel for treatment of tobacco induced Homogenous Leukoplakia – A Randomised clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RMRC - 1280  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha Singh 
Designation  Post Graduate Student 
Affiliation  K.L.E.V.K Institute of Dental Sciences 
Address  Department of Oral Medicine and Radiology, K.L.E.V.K. Institute of Dental Sciences, Nehru Nagar
Department of Oral Medicine and Radiology, K.L.E.V.K. Institute of Dental Sciences, Nehru Nagar
Belgaum
KARNATAKA
590010
India 
Phone  9620467333  
Fax    
Email  manishasingh1831988@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjana Bagewadi 
Designation  Professor and Head of the Department 
Affiliation  K.L.E.V.K Institute of dental sciences 
Address  Department of Oral Medicine and Radiology, K.L.E.V.K. Institute of Dental Sciences, Nehru Nagar
Department of Oral Medicine and Radiology, K.L.E.V.K. Institute of Dental Sciences, Nehru Nagar
Belgaum
KARNATAKA
590010
India 
Phone  9620467333  
Fax    
Email  anjanabagewadi455@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manisha Singh 
Designation  Post Graduate Student 
Affiliation  K.L.E.V.K Institute of dental sciences 
Address  Department of Oral Medicine and Radiology, K.L.E.V.K. Institute of Dental Sciences, Nehru Nagar
Department of Oral Medicine and Radiology, K.L.E.V.K. Institute of Dental Sciences, Nehru Nagar
Belgaum
KARNATAKA
590010
India 
Phone  9620467333  
Fax    
Email  manishasingh1831988@gmail.com  
 
Source of Monetary or Material Support  
Mr Dilip Kumar Singh Horticulture Officer,NTPC Limited,Barh,Bihar 
 
Primary Sponsor  
Name  Manisha Singh 
Address  Post Graduate Student KLE VK Institute of Dental Sciences,Nehrunagar,Belgaum 
Type of Sponsor  Other [Self] 
 
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 
Manisha Singh  K.L.E.V.K Institute of Dental Sciences  Department of Oral Medicine and Radiology,K.L.E University,Nehrunagar
Belgaum
KARNATAKA 		 9620467333

manishasingh1831988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Research and Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HOMOGENOUS LEUKOPLAKIA, (1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calendula Officinalis   Calendula officinalis extract gel containing antioxidants 2mg by weight, per gram of gel TID for 1 month  
Intervention  Lycopene  lycopene gel containing lycopene antioxidant 2mg by weight, per ml of gel TID for 1 month 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Tobacco induced, clinically diagnosed, histopathologically confirmed cases of homogeneous leukoplakia measuring not less than 1.5 cm in area bidimensionally.
Age group 20 to 60 years.
Patients willing to participate in the study.
 
 
ExclusionCriteria 
Details  Patients with potentially malignant disorders other than homogeneous leukoplakia.
Past history of major illness within a period of 6 months.
Patients with known allergy to Asterceae family
Patients with known allergy to lycopene
Pregnant and Lactating females.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase/decrease in the size of the lesion  1 and half year 
 
Secondary Outcome  
Outcome  TimePoints 
No change in the size of lesion  1 and half year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "2"
Final Enrollment numbers achieved (India)="2" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2015 
Date of Study Completion (India) 31/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Wanted to go ahead with the publication. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manishasingh1831988@gmail.com].

  6. For how long will this data be available start date provided 01-03-2015 and end date provided 30-03-2017?
    Response (Others) -  Already published.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Oral Leukoplakia is the most common potentially malignant disorder of the oral mucosa. It has been reported that between 16% and 62% of oral squamous cell carcinomas are associated with oral Leukoplakia. Early diagnosis and treatment of these potentially malignant disorders is required to prevent their progression to malignancy.Current treatment modalities include cessation of tobacco chewing habit and Lycopene as a powerful antioxidant.Many herbal medicines have been tried in management of oral diseases including premalignancies. Calendula Officinalis is one among the herbal medicines which has the potential antioxidant property.Calendula officinalis also known as pot marigold is an annual herb belonging to family Asteraceae.Research has shown that Calendula officinalis contains flavonoids,polyphenols,lutein,flavoxanthin,lycopene,auroxanthin,betacarotene which possesses antioxidant property.
The Aim of this research work is to assess the efficacy of Calendula Officinalis gel as cost effective treatment modality in comparison to Lycopene gel in treatment of Leukoplakia.
Sixty patients of either sex with clinically diagnosed and histopathologically confirmed cases of homogenous leukolplakia were selected reporting to department of Oral medicine and Radiology,KLE.Patients with potentially malignant disorders other than homogenous leukoplakia,any past history of major illness within a period of 6 months,allergy to Asterceae family and lycopene were excluded.Patients included 60 clinically and histopathologically confirmed cases of homogenous leukoplakia based on the which were randomly divided into Group I and Group II with 30 patients each.Group I patients were dispensed Calendula Officinalis extract gel whereas Group II patients were given Lycopene gel.Tobacco cessation counseling was done for all patients at the very first appointment and they were instructed to apply the gel thrice daily after breakfast,lunch and dinner. The therapy was instituted for 1 month to assess the change in size of lesion at the baseline and post treatment(at the end of 1 month).The data obtained was statistically analyzed by paired t test and unpaired t test.
The results revealed a statistically significant difference in both Group I and Group II when the pre and post treatment results were compared in the same group.The intergroup comparison for the evaluation of reduction in size of the lesion did not reveal statistically significant results.Hence the study concluded that Calendula Officinalis extract gel can be effectively used as an alternative to conventional treatment modality.
 
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