| CTRI Number |
CTRI/2024/07/071001 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing effect Of Nicotine Replacement Therapy, Laser Therapy and Behavioural Counselling for quitting tobacco -A Parallel Randomized Clinical Trial. |
|
Scientific Title of Study
|
Comparative evaluation of effect Of pharmacotherapy, laser therapy and behavioural counselling on tobacco cessation-A parallel randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Neha Shukla |
| Designation |
Senior Resident |
| Affiliation |
Faculty of Dental Sciences, Banaras Hindu University. |
| Address |
Room No 8, Fourth Floor, Unit of Public Health Dentistry, Faculty of Dental Sciences, IMS Banaras Hindu University , Varanasi- 221005, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8853826867 |
| Fax |
|
| Email |
drnehashukla20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Khairnar |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Dental Sciences, Banaras Hindu University |
| Address |
Room No 8,Fourth Floor, Unit of Public Health Dentistry, Faculty of Dental Sciences, IMS Banaras Hindu University , Varanasi- 221005, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8853826867 |
| Fax |
|
| Email |
kmahesh222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Khainar |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Dental Sciences, Banaras Hindu University. |
| Address |
Room No 8, Fourth Floor, Unit of Public Health Dentistry, Faculty of Dental Sciences, IMS Banaras Hindu University , Varanasi-221005, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8853826867 |
| Fax |
|
| Email |
kmahesh222@gmail.com |
|
|
Source of Monetary or Material Support
|
| faculty of dental sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh INDIA. PINCODE 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Shukla |
| Address |
Room no 8, Fourth Floor, Unit of Public Health Dentistry Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi-221005 Uttar Pradesh. |
| Type of Sponsor |
Other [SELF. No sponser by any institution and it will be self sponsored by the primary investigator] |
|
|
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 Neha Shukla |
Banaras Hindu University |
Room No 8 , Fourth floor, Unit of Public Health Dentistry, Faculty of Dental Sciences, Banaras Hindu University, Varanasi 221005 Uttar Pradesh
Varanasi
UTTAR PRADESH |
8853826867
drnehashukla20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants having a habit of tobacco consumption |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Behavioural counselling |
Participants were provided tobacco cessation counselling once weekly for one month interval |
| Intervention |
laser |
participants were provided laser therapy once weekly for one month interval. |
| Intervention |
Nicotine lozenges, Laser therapy, Behavioural therapy |
Nicotine Therapy dose given per week is 2mg as per intake of tobacco.
Laser therapy given using photodynamic therapy at 680nm wavelength
Behavioural therapy done by giving motivation by Ask, Advise, Assist, Arrange & followup |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants should be above 18-45 year old .
2.Participants should be current tobacco users with low to moderate nicotine dependence are included.
3.Participants who are self-willing to quit tobacco.
|
|
| ExclusionCriteria |
| Details |
1.Known patients of diabetes mellitus, cardiac problem, epilepsy, people lacking skin sensation, immunocompromised individuals, patients with autoimmune diseases, severe skin lesions people suffering from undiagnosed fever, infection at and around the acupuncture points.
2. People who are on psychiatric medication and unable to comply with scheduled appointment.
3. People using Roaccutane at any time with in the last six months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and compare nicotine dependence among tobacco users before and one month after having Nicotine lozenges , lazer therapy and behavioural counselling.
2. To evaluate and compare salivary cotinine level before and one month after having Nicotine lozenges, lazer therapy and behavioural counselling.
3. To evaluate and compare urine cotinine level before and one month after having Nicotine lozenges , lazer therapy and behavioural counselling
|
at the end of one month time interval
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare physical effect due to tobacco use before and one month after having Nicotine lozenges, lazer therapy and behavioural counselling.
|
at the end of one month time interval |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is randomised controlled trial will be conducted for a period of one month on 60 individuals which will be randomly selected into three groups which is nicotine lozenge group , laser group and behavioural counsling group. This study will investigates the understanding of smokeless tobacco users regarding the health risk of habit, addressing its high prevalence in the population. This will be helpful in timely insights to guide effective public health interventions and curb tobacco-related health risks, promoting healthier behaviours in the population. However no literature has compared which technique can be best used amongst each or should it be in the combination and permutation of these techniques. Hence present study will be conducted to assess the comparison on effectiveness of pharmacotherapy ,laser therapy and behavioural counselling in tobacco cessation among smokeless tobacco users in Varanasi city |