The Effect of Honey on Lessening the Withdrawal Symptoms

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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Withdrawal Symptoms
• Intervention / Treatment: Dietary supplement: Honey; Dietary supplement: Water

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung-shan Hung, Ph.D; Phone Number: 17617 886-3-8561825; Email: cshung@gms.tcu.edu.tw

Study Locations

• Taiwan
  • Hualien City, Taiwan, 970
    • Recruiting
    • Hualien Tzu Chi Hospital
    • Contact: Chung-shan Hung, Ph.D; Phone Number: 17617 886-38561825

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants need to drink honey every day for four weeks.	Dietary supplement: Honey; Participants need to drink honey every day for four weeks.
Placebo Comparator: Control group; Participants need to drink water every day for four weeks.	Dietary supplement: Water; Participants need to drink water every day for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome
• Other Study ID Numbers: P00001592

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No