Smoking CessationNCT05264428
The Effect of Honey on Lessening the Withdrawal Symptoms
A study testing Honey and Water in people with Smoking Cessation and Withdrawal Symptoms, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Withdrawal Symptoms
- What is being tested?
- Honey and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Sep 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the cessation clinic patients aged more than 18
- only take Champix for smoking cessation
Who cannot join
- diabetes, cancer, renal disease
- with wet and hot body constitution
- allergic to honey
- accepting traditional Chinese medicine intervention
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital
Hualien City, 970
Chung-shan Hung, Ph.D, 886-38561825 ext. 17617
About this study
Official title: 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.
- Conditions
- Smoking Cessation, Withdrawal Symptoms
- Being tested
- Honey, Water
- Medical subject headings
- Smoking Cessation, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyDietary supplement
Participants need to drink honey every day for four weeks.
WaterDietary supplement
Participants need to drink water every day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants need to drink honey every day for four weeks. Receives: Dietary Supplement: Honey |
| Control group | Placebo comparator | Participants need to drink water every day for four weeks. Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and after the 4-week trial
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after the 4-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start3 Sep 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264428
- Sponsor's protocol ID
- P00001592
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Honey on Lessening the Withdrawal Symptoms According to the Body Constitution
- ClinicalTrials.gov ID
- NCT05264428
- Acronym / sponsor ID
- P00001592
- Conditions
- Smoking Cessation, Withdrawal Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: HoneyParticipants need to drink honey every day for four weeks. |
| Control group | Placebo comparator | Dietary Supplement: WaterParticipants need to drink water every day for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the cessation clinic patients aged more than 18
- only take Champix for smoking cessation
Key exclusion criteria (4 listed)
- diabetes, cancer, renal disease
- with wet and hot body constitution
- allergic to honey
- accepting traditional Chinese medicine intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoneyParticipants need to drink honey every day for four weeks. | Dietary supplement | Experimental group |
| WaterParticipants need to drink water every day for four weeks. | Dietary supplement | Control group |
Primary outcome
Fagerstrom Test for Nicotine Dependence
Time frame: Before and after the 4-week trial, 3 and 6 months after the trial
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
Time frame: Before and after the 4-week trial
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.
6 secondary outcomes
Body Constitution Questionnaire
Time frame: Before and after the 4-week trial
Tobacco Craving Questionnaire
Time frame: Before and after the 4-week trial
Depression Anxiety Stress Scales-21
Time frame: Before and after the 4-week trial
WHOQOL-BREF
Time frame: Before and after the 4-week trial
Pittsburgh sleep quality index
Time frame: Before and after the 4-week trial
Readiness to Quit Ladder
Time frame: Before and after the 4-week trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey and Water in people with Smoking Cessation and Withdrawal Symptoms, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung-shan Hung, Ph.D (886-3-8561825 ext. 17617, cshung@gms.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerstrom Test for Nicotine Dependence (time frame: Before and after the 4-week trial, 3 and 6 months after the trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.