FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024462 [Registered on: 03/04/2020] Trial Registered Prospectively
Last Modified On: 06/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Yoga & Naturopathy
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   To compare the effectiveness of using nicotine chewing gum with behavioral counselling versus doing yoga with behavioral counselling in quitting tobacco among Delhi government bus drivers: Cluster Randomized Trial 
Scientific Title of Study   Effectiveness of behavioral counselling with nicotine gum versus behavioral counselling with Yoga on tobacco cessation among Delhi Government Bus Drivers: Cluster Randomized Trial  
Trial Acronym  YITC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shristy Sharma  
Designation  Post Graduate Student 
Affiliation  Maulana Azad Institute of Dental Sciences  
Address  5th Floor, Department Of Public Health Dentistry, Mualana Azad Institute of Dental Sciences, New Delhi 110002, India

Central
DELHI
110002
India 
Phone  8860890417  
Fax    
Email  shristysharma9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VIKRANT MOHANTY  
Designation  PROFESSOR AND HOD OF PUBLIC HEALTH DENTISTRY  
Affiliation  Maulana Azad Institute of Dental Sciences  
Address  5th Floor, Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi 110002 India

Central
DELHI
110002
India 
Phone  09654700983  
Fax    
Email  vikrantmohanty@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vikrant Mohanty 
Designation  Professor And Head of Department of Public Health Dentistry 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  5th floor, Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi DELHI 110002 India

Central
DELHI
110002
India 
Phone  09654700983  
Fax    
Email  vikrantmohanty@gmail.com  
 
Source of Monetary or Material Support  
Self, 5th floor, Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi- 110002 
 
Primary Sponsor  
Name  Shristy Sharma 
Address  5th floor, Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi- 110002 
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 
SHRISTY SHARMA   RAJGHAT DEPOT 1 & 2  New, RPS Complex, Raj Ghat, New Delhi, Delhi 110002
Central
DELHI 		 8860890417

shristysharma9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAIDS Ethical 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 
Comparator Agent  Behavioral counselling with nicotine replacement therapy  Nicotine replacement therapy Dosage 2 mg AND 4 mg depending upon the patients tobacco usage. Route of administration- oral total duration 12 weeks. Schedule- for first 6 Weeks- one gum every 1-2 hours for 6-10 weeks one gum every 2-4 hours for 10-12 weeks- one gum every 4-8 hours or when craving occurs 
Intervention  Behavioral Counselling with Yoga in Tobacco Cessation  Behavioral Counselling to motivate patients to quit tobacco and teaching yoga exercises to deal with the withdrawal symptoms  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. A daily smoke/ smokeless/ mixed form of tobacco users
2. Those who will give consent and are able to read and write local language
3. Patients having medium dependence score according to fagerstrom scale for smoking and modified fagerstrom scale for smokeless tobacco.

 
 
ExclusionCriteria 
Details  1 Participants not willing to participate.
2 Participants who are completely edentulous.
3 Participants suffering from TMJ problems.
4 Participants practicing yoga regularly.
5 Participants who have used/ using nrt or experienced side-effects due to nrt.
6 Participants who are medically compromised in
which practicing yoga is contraindicated.
7 Participants with dental emergency.
8 Participants who consume alcohol.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of two methods on the basis of quit status; quit reduction and status quo. To assess and compare the biochemically verified urine cotinine levels using qualitative test at different time intervals among both group  0 day, 1st week, 1st month, 3rd month, 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare knowledge, attitude and practice regarding tobacco cessation and its ill effects
To measure oral health status of bus drivers
To develop yoga protocol for tobacco cessation based on the study
 		 0 day, 1st week, 1st month, 3rd month, 6th month 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/08/2020 
Date of Study Completion (India) 30/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The tobacco epidemics is one of the biggest public health threats the world has ever faced. According to the reports of WHO , tobacco is the single greatest cause of the preventable deaths globally. It is estimated that there are more than one billion current tobacco users in the world, of whom 80% live in low and middle income countries. in 2015 11.5% of the global deaths were attributed to tobacco use worldwide, of which 52.5% took place in the four countries (China, India, USA and Russia) . Unlike developed countries, where behavioral therapies and/ or pharmacotherapy is provided at little or no cost to patients, support services are very limited for quitting tobacco in India.it has been estimated that two-third of the world’s population seeks healthcare from sources other than those providing treatment with the allopathic system of medicine. In India complementary alternative medicine therapies which are scientifically appropriate and culturally acceptable like Ayurveda, Yoga and Naturopathy, Unani-tibbi, Siddha and Homeopathy, have been practiced since a long time. considering the withdrawal symptoms of nicotine, among these therapies a promising and affordable option in context of India is the use of Yogic exercises. It is one of the traditional method to achieve good physical and mental health and thus compliance of the patients with this method of tobacco cessation is expected to be high. 
Among these employees, bus drivers form an important group belonging to low-medium socioeconomic strata. they are exposed to high level of work demands. And hence more prone to the habit of tobacco consumption. Thus yoga may help in such low-medium socioeconomic strata in quitting the tobacco consumption habit.
Thus this study aim to assess and compare the effectiveness of yoga and behavioral counselling versus nicotine replacement therapy with behavioral counselling among Delhi Government Bus Drivers.    
 
Close