A Clinical Study To Evaluate the Efficacy of Devdarvyadi Dhoomra in Tobacco Smoking Withdrawal Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in clinical manifestation of Tobacco smoking withdrawal syndrome on the basis of DSM 5 criteria
研究概览
简要总结
Tobacco includes nicotine and 4000 other chemicals .Nicotine has a powerful tendency to addict, when taken again and again . Excessive use of tobacco products leads to clinical changes in the oral mucosa resulting in gum disease, oral cancers such as leukoplakia and tumors . As there is a lack of description in this field of concern, the need of the study about toabcco abuse and its withdrawal management is very much important .
So it is hypothesised that with the dhoomra ( herbal smoking ) can produce the good feel effect and it will produce placebo effect . Simultaneously it will subside the tobacco dependence. As the content of this dhoomra having medhya effect so it can correct the altered brain function caused by tobaccco consumption .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patient of tobacco smoking addiction only.
- •Clinical manifestation of tobacco smoking withdrawal patient including craving for nicotine anxiety depression restlessness Patient having history of Tobacco smoking more than 1 year Either sex Patient having Fagerstrom for Nicotine Dependence score ranging 5 to 10.
排除标准
- •Tobacco smoking addicted patient suffering from cancer Tobacco smoking addicted patient who are suffering from major psychiatric disorders Tobacco smoking addicted patients suffering from major systemic illness like myocardial infraction ischemic heart disease pulmonary tuberculosis diabetes mellitus hypertension Patient having Fagerstrom for Nicotine Dependence score ranging 0 to 4.
结局指标
主要结局
Changes in clinical manifestation of Tobacco smoking withdrawal syndrome on the basis of DSM 5 criteria
时间窗: 45 days
次要结局
- Changes in Liver Function Test, Lipid profile(Changes in Spirometry Volume and Capacity)
研究者
Professor Anita Sharma
National Institute of Ayurveda