ChiCTR2000033650已完成Unknown
Chinese Medicine Acupuncture Combined with Auricular Acupressure for Smoking Cessation (the Guangdong-Hong Kong-Macau Greater Bay Area)
This study for Hong Kong sites do not receive specific funding.0 个研究点目标入组 30 人开始时间: 2020年9月24日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- The success rate of smoking cessation at week 24
研究概览
简要总结
This study aim to verify the safety and efficacy of acupuncture combined with auricular acupressure on smoking cessation, and evaluate the cost-effectiveness of acupuncture-based smoking cessation; to develop a generalizable, practical, self-operable but medically intervened acupuncture-based smoking cessation regimen, complement the China Clinical Smoking Cessation Guideline with acupuncture-based smoking cessation, and provide sufficient clinical research evidence.
研究设计
- 研究类型
- Interventional
- 主要目的
- 单臂
- 盲法
- N/a
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) voluntarily quit smoking;
- •(2) aged 18-65 years Chinese;
- •(3) have a smoking duration >= 1 year;
- •(4) have a smoking quantity >= 20 cigarettes per day (CPD) in the past year;
- •(5) show a positive test for salivary cotinine;
- •(6) have a Fagerstrom test for nicotine dependence (FTND) score >= 4 (moderate and severe smokers);
- •(7) have provided informed consent and volunteered to participate;
- •(8) have undergone a washout period of more than one month if other smoking cessation treatments were previously conducted.
排除标准
- •(1) severe and unstable cardiac, pulmonary, cerebral, and hematologic diseases, or diabetes with other complications; (2) mental illness and drug abuse;
- •(3) stroke or nervous system diseases;
- •(4) unknown diseases;
- •(5) coagulopathy or current administration of anticoagulant drugs;
- •(6) moderate or severe liver and kidney impairment;
- •(7) pregnant women;
- •(8) those with a history of smoking cessation treatments such as acupuncture, auricular acupressure, or nicotine replacement therapy within the past one month.
研究组 & 干预措施
Case series
acupuncture combined with auricular acupressure
结局指标
主要结局
The success rate of smoking cessation at week 24
次要结局
- The success rate of complete smoking cessation
- The success rate of smoking cessation at other time points
- Exhaled carbon monoxide level
- Salivary cotinine level
- Fagerstrom test for nicotine dependence (FTND) score
- Autonomy over smoking scale (AUTOS) score
- Hamilton anxiety rating scale (HAMA) score
- Self-rating anxiety scale (SAS) score
- Pittsburgh sleep quality index (PSQI) Score
研究者
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