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The Effect of Honey on Lessening the Withdrawal Symptoms

Primary Purpose

Smoking Cessation, Withdrawal Symptoms

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Honey

Water

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Participants need to drink honey every day for four weeks.

Participants need to drink water every day for four weeks.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05264428

First Posted

February 11, 2022

Last Updated

March 2, 2022

Sponsor

Buddhist Tzu Chi General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05264428

Brief Title

The Effect of Honey on Lessening the Withdrawal Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 3, 2021 (Actual)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Withdrawal Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Participants need to drink honey every day for four weeks.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Participants need to drink water every day for four weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Honey

Intervention Description

Participants need to drink honey every day for four weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Water

Intervention Description

Participants need to drink water every day for four weeks.

Primary Outcome Measure Information:

Title

Fagerstrom Test for Nicotine Dependence

Description

Time Frame

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

Title

Minnesota Nicotine Withdrawal Scale

Description

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