Efficacy of an Ayurvedic herbal lozenge for nicotine withdrawal – A Preclinical and Pilot clinical study for tobacco cessation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Decrease in severity and frequency of withdrawal symptoms assessed by POMS (Profile of Mood State) and questionnaire using the Likert scale.
研究概览
简要总结
This study aims to evaluate the efficacy of an Ayurvedic herbal lozenge in managing nicotine withdrawal and supporting tobacco cessation. Tobacco use is a major global health problem, responsible for millions of deaths annually, and current pharmacological options for de-addiction have limitations.
Ayurvedic texts describe concepts like Dushi Visha (chronic toxins) and Dhumopahat (smoke-induced disorders), which parallel the modern understanding of long-term tobacco toxicity. Based on classical references and contemporary evidence, a novel herbal lozenge formulation has been developed, containing herbs with dopaminergic, nootropic, antioxidant, and mucosal-soothing properties.
The research will be conducted in two phases:
- Preclinical phase – assessing safety and preliminary efficacy in animal models.
- Pilot clinical study – testing the lozenge in human participants with tobacco dependence, focusing on withdrawal symptoms, craving reduction, and safety.
The expected outcome is to generate preliminary scientific evidence supporting the use of an Ayurvedic herbal lozenge as a safe, effective, and integrative option for tobacco cessation, paving the way for larger controlled clinical trials.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants having a history of smoking a minimum of 5 cigarettes daily.
- •Willing to quit (assessed by RCQ greater than 5) and provide written consent for intervention and follow-up of 45 days in the study.
排除标准
- •Participants with major illness.
- •Those having associated addiction or substance abuse, and smokeless tobacco users.
- •Uncontrolled hypertension(greater than 160 mmHg) or diabetes.
- •Pregnant and lactating women.
- •Any significant psychiatric illness or mood disorders.
- •Those taking any anti-smoking medication or nicotine replacement therapy(NRT) in the previous month.
- •Those who are taking any other medications interfering with the treatment protocol.
- •Those with known hypersentivity to any ingredients of the study drug.
- •Those who are not willing to participate.
结局指标
主要结局
Decrease in severity and frequency of withdrawal symptoms assessed by POMS (Profile of Mood State) and questionnaire using the Likert scale.
时间窗: Intervention period - 1 month | Follow up - 15 days
次要结局
- Reduction in smoking (number of cigars taken per day) assessed using the Fagerstrom Test for Nicotine Dependence (FTND) scale.(Intervention period - 1 month)
研究者
Dr Sree Lakshmi J
All India Institute of Ayurveda