Comparative evaluation of effect Of pharmacotherapy, laser therapy and behavioural counselling on tobacco cessation-A parallel randomized clinical trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To evaluate and compare nicotine dependence among tobacco users before and one month after having Nicotine lozenges , lazer therapy and behavioural counselling.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •People who are on psychiatric medication and unable to comply with scheduled appointment.
- •People using Roaccutane at any time with in the last six months.
结局指标
主要结局
1.To evaluate and compare nicotine dependence among tobacco users before and one month after having Nicotine lozenges , lazer therapy and behavioural counselling.
时间窗: at the end of one month time interval
2. To evaluate and compare salivary cotinine level before and one month after having Nicotine lozenges, lazer therapy and behavioural counselling.
时间窗: at the end of one month time interval
3. To evaluate and compare urine cotinine level before and one month after having Nicotine lozenges , lazer therapy and behavioural counselling
时间窗: at the end of one month time interval
次要结局
- To evaluate and compare physical effect due to tobacco use before and one month after having Nicotine lozenges, lazer therapy and behavioural counselling.
研究者
DR Neha Shukla
Faculty of Dental Sciences, Banaras Hindu University.