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CTRI Number  CTRI/2024/08/072674 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry
Other (Specify) [Herbal]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to compare the effectiveness of herbal hard candy lozenges and Nicotine lozenges to help in tobacco cessation and healing of tobacco related oral lesions. 
Scientific Title of Study   Development of a novel innovative herbal formulation to reduce tobacco withdrawal symptoms and promote healing of tobacco related oral lesions. 
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 Chandrashekar B R 
Designation  Professor and Guide 
Affiliation  JSS Dental College and Hospital 
Address  Room No. 8, Department of Public Health Dentistry, Jagadguru Sri Shivarathreeshwara Dental College and Hospital, JSS Academy of Higher Education and Research, Mysore

Mysore
KARNATAKA
570015
India 
Phone  8197705773  
Fax    
Email  drchandrashekarbr_dch@jssuni.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrashekar B R 
Designation  Professor and Guide 
Affiliation  JSS Dental College and Hospital 
Address  Room No. 8, Department of Public Health Dentistry, Jagadguru Sri Shivarathreeshwara Dental College and Hospital, JSS Academy of Higher Education and Research, Mysore

Mysore
KARNATAKA
570015
India 
Phone  8197705773  
Fax    
Email  drchandrashekarbr_dch@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nishath Khanum 
Designation  Ph.D. Research Scholar 
Affiliation  JSS Dental College and Hospital 
Address  Room No.8, Department of Public Health Dentistry, JSS Dental College and Hospital, JSS AHER, Mysore

Mysore
KARNATAKA
570015
India 
Phone  9008118098  
Fax    
Email  nishathkhanum@jssuni.edu.in  
 
Source of Monetary or Material Support  
JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysore - 570015, Karnataka, India 
 
Primary Sponsor  
Name  Dr. Chandrasheksr B R 
Address  Room no. 8, Department of Public Health Dentistry, JSS Dental College and Hospital, JSS AHER, Mysore 
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 
Dr Nishath Khanum  JSS Dental College and Hospital  Room No. 8, Department of Public Health Dentistry
Mysore
KARNATAKA 		 9008118098

nishathkhanum@jssuni.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Dental College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F172||Nicotine dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Herbal hard candy lozenges consisting of Tulsi leaves extract 50 mg, Turmeric extract 50 mg, Oats extract 37.5 mg, and Guava leaves extract 25 mg.  The lozenges will be administered 3 times per day for a period of 3 months and follow up will be done at the end of each month. 
Comparator Agent  Nicotine 2 mg lozenges  The Lozenges will be given for 3 times per day for a period of 3 months and follow up will be done at the end of each month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18 to 65 years with a history of tobacco use both smoking and smokeless forms of tobacco.
History of tobacco use for at least 6 months.
Tobacco users with related non malignant oral lesions.
Willingness to reduce daily use of tobacco based on Richmond test.
Patients willing to give informed consent.
Fagerstrom test for Nicotine dependence score of 4 points and more.

 
 
ExclusionCriteria 
Details  Patients on antidepressant or antipsychotic medication.
Patients with known allergy to any of the herbs used in the formulation.
Patients using any other medication for tobacco or alcohol dependence.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The efficacy of the intervention in reducing the tobacco withdrawal symptoms will be assessed using the Minnesota Tobacco Withdrawal Scale and the tobacco dependence will be assessed using Fagerstrom Test for Nicotine Dependence.
Complete abstinence and partial reduction in tobacco use will be assessed.
To determine the healing of tobacco related oral lesions three-point rating scale for pain and size of the lesion in millimeters will be recorded. 		 At baseline, at the end of each month for a period of 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Salivary Cotinine tests will be done to confirm a reduction in tobacco use.  At baseline and at the end of 3 months. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/09/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nishathkhanum@jssuni.edu.in].

  6. For how long will this data be available start date provided 30-03-2025 and end date provided 30-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The harm caused by tobacco use among people who are willing and unwilling to quit can be reduced by the development of herbal formulations that can facilitate tobacco cessation with fewer side effects. The present study is a randomized, double blind, active controlled trial comparing the efficacy of  herbal hard candy lozenges and Nicotine lozenges in reducing tobacco withdrawal symptoms and also determining the efficacy of  the herbal lozenges in promoting healing of tobacco related oral lesions. The lozenges will be given three times daily for a period of 3 months. The primary outcome measures will be to determine the reduction in tobacco withdrawal symptoms, continuous and point abstinence rate and decrease in the severity of the tobacco related oral lesions. The secondary outcome will be measured in the form of Salivary Cotinine to confirm a reduction in the tobacco intake.
 
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