The Effect of Honey on Lessening the Withdrawal Symptoms

N/AUnknownNCT05264428

Buddhist Tzu Chi General Hospital100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Smoking Cessation Withdrawal Symptoms

Interventions

HoneyDIETARY_SUPPLEMENT

Participants need to drink honey every day for four weeks.

WaterDIETARY_SUPPLEMENT

Participants need to drink water every day for four weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Before and after the 4-week trial

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Chung-shan Hung, Ph.D

CONTACT

886-3-8561825 cshung@gms.tcu.edu.tw

Data from ClinicalTrials.gov

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