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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
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
February 11, 2022
Last Updated
March 2, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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
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
Before and after the 4-week trial
Secondary Outcome Measure Information:
Title
Body Constitution Questionnaire
Description
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
Title
Tobacco Craving Questionnaire
Description
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
Title
Depression Anxiety Stress Scales-21
Description
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
Title
WHOQOL-BREF
Description
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.
Time Frame
Before and after the 4-week trial
Title
Pittsburgh sleep quality index
Description
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.
Time Frame
Before and after the 4-week trial
Title
Readiness to Quit Ladder
Description
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.
Time Frame
Before and after the 4-week trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung-shan Hung, Ph.D
Phone
886-3-8561825
Ext
17617
Email
cshung@gms.tcu.edu.tw
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung-shan Hung, Ph.D
Phone
886-38561825
Ext
17617

12. IPD Sharing Statement

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The Effect of Honey on Lessening the Withdrawal Symptoms

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