Randomised Comparative Clinical Trial Of Jyotishmati Lozenges For The Withdrawal Effects Due To Tobacco Smoking Addiction
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Effect of Jyotishmati lozenges in tobacco smokers in reduction of withdrawal effects
研究概览
简要总结
Very little work has been done on the role of natural herbal agents in smoking cessation. This clinical trial was designed to determine the effectiveness and mode of action of natural herbal agents in smoking cessation. To assess the effect of Jyotishmatyadi lozenges on the withdrawal effect due to tobacco smoking, a randomized comparative clinical trial of Jyotishmatyadi lozenges for the Withdrawal effect due to tobacco smoking addiction is designed. The objective of the study is to assess the effect of Jyotishmatyadi lozenges on the withdrawal effect due to tobacco smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •individuals from 15 to 60 years will be included
- •individuals of both sexes will be included
- •Only tobacco smokers will be selected.
排除标准
- •All types of known malignancies
- •All types of oral lesions having any known underlying systemic pathology, such as syphilis, systemic lupus erythematous
- •Without a history of tobacco smoking addiction.
结局指标
主要结局
Effect of Jyotishmati lozenges in tobacco smokers in reduction of withdrawal effects
时间窗: baseline 0 day assessment | 15th day | 30th day | 45th day and 60th day assessment Total 4 follow ups
次要结局
- To assess palatability of jyotoshmati lozenges(To assess adverse events if any)
研究者
Dr Yadunath Waykole
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri, Pune, 18