跳至主要内容
临床试验/NCT05264428
NCT05264428Unknown不适用

The Effect of Honey on Lessening the Withdrawal Symptoms According to the Body Constitution

Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Fagerstrom Test for Nicotine Dependence

研究概览

简要总结

This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •the cessation clinic patients aged more than 18
  • •only take Champix for smoking cessation

排除标准

  • •diabetes, cancer, renal disease
  • •with wet and hot body constitution
  • •allergic to honey
  • •accepting traditional Chinese medicine intervention

研究组 & 干预措施

Control group

Placebo Comparator

Participants need to drink water every day for four weeks.

干预措施: Water (Dietary Supplement)

Experimental group

Experimental

Participants need to drink honey every day for four weeks.

干预措施: Honey (Dietary Supplement)

结局指标

主要结局

Fagerstrom Test for Nicotine Dependence

时间窗: Before and after the 4-week trial, 3 and 6 months after the trial

Change from baseline Fagerstrom Test for Nicotine Dependence at 4 weeks, 3 and 6 months after the trial. Fagerstrom Test for Nicotine Dependence is ranged from 0-10. The higher score the higher dependence on Nicotine.

Minnesota Nicotine Withdrawal Scale

时间窗: Before and after the 4-week trial

Change from baseline Minnesota Nicotine Withdrawal Scale at 4 weeks. The Minnesota Nicotine Withdrawal Scale is ranged from 0-84. The higher score indicates more severe withdrawal syndromes.

次要结局

  • Readiness to Quit Ladder(Before and after the 4-week trial)
  • WHOQOL-BREF(Before and after the 4-week trial)
  • Body Constitution Questionnaire(Before and after the 4-week trial)
  • Tobacco Craving Questionnaire(Before and after the 4-week trial)
  • Depression Anxiety Stress Scales-21(Before and after the 4-week trial)
  • Pittsburgh sleep quality index(Before and after the 4-week trial)

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验