The Effect of Honey on Lessening the Withdrawal Symptoms

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264428
• Other study ID #: P00001592
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2022
• Source: Buddhist Tzu Chi General Hospital
• Contact: Chung-shan Hung, Ph.D
• Phone: 886-3-8561825
• Email: cshung[@]gms.tcu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• the cessation clinic patients aged more than 18

• only take Champix for smoking cessation

Exclusion Criteria:

• diabetes, cancer, renal disease

• with wet and hot body constitution

• allergic to honey

• accepting traditional Chinese medicine intervention

Related Conditions & MeSH terms

• Smoking Cessation
• Substance Withdrawal Syndrome
• Withdrawal Symptoms

Intervention

Dietary Supplement:
• Honey
Participants need to drink honey every day for four weeks.
• Water
Participants need to drink water every day for four weeks.

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fagerstrom Test for Nicotine Dependence	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.	Before and after the 4-week trial, 3 and 6 months after the trial
Primary	Minnesota Nicotine Withdrawal Scale	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.	Before and after the 4-week trial
Secondary	Body Constitution Questionnaire	Change from baseline Body Constitution Questionnaire at 4 weeks. The Body Constitution Questionnaire contains 9 sub-scales, each is ranged from 0-100. The higher score indicates the likelihood of the body constitution.	Before and after the 4-week trial
Secondary	Tobacco Craving Questionnaire	Change from baseline Tobacco Craving Questionnaire at 4 weeks. The Tobacco Craving Questionnaire contains 47 items that ranged from 1-7. The higher score indicates the higher craving for tobacco.	Before and after the 4-week trial
Secondary	Depression Anxiety Stress Scales-21	Change from baseline Depression Anxiety Stress Scales-21 at 4 weeks. The Depression Anxiety Stress Scales-21 contains 3 sub-scales, each is scored form 0-28. The higher score indicates the more negative condition.	Before and after the 4-week trial
Secondary	WHOQOL-BREF	Change from baseline WHOQOL-BREF at 4 weeks. WHOQOL-BREF contains 4 domains, each domain will be calculated to a score ranged from 0-100. The score of 100 indicates satisfaction of QOL.	Before and after the 4-week trial
Secondary	Pittsburgh sleep quality index	Change from baseline Pittsburgh sleep quality index at 4 weeks. The Pittsburgh sleep quality index ranged from 0 to 21. The higher score indicates more severe difficulties in sleep.	Before and after the 4-week trial
Secondary	Readiness to Quit Ladder	Change from baseline Readiness to Quit Ladder at 4 weeks. The Readiness to Quit Ladder is rated from 1 to 10. The higher score indicated better readiness to quit smoking.	Before and after the 4-week trial