Development of a novel innovative herbal formulation to reduce tobacco withdrawal symptoms and promote healing of tobacco related oral lesions.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: At baseline, at the end of each month for a period of 3 months.
Complete abstinence and partial reduction in tobacco use will be assessed.
时间窗: At baseline, at the end of each month for a period of 3 months.
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.
时间窗: At baseline, at the end of each month for a period of 3 months.
次要结局
- Salivary Cotinine tests will be done to confirm a reduction in tobacco use.(At baseline and at the end of 3 months.)
研究者
Dr Chandrashekar B R
JSS Dental College and Hospital