The Effect of Honey on Lessening the Withdrawal Symptoms

NCT05264428 | Unknown

• 1 other identifier: P00001592
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation; Withdrawal Symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Body Constitution Questionnaire

  Before and after the 4-week trial

• Tobacco Craving Questionnaire

  Before and after the 4-week trial

• Depression Anxiety Stress Scales-21

  Before and after the 4-week trial

• WHOQOL-BREF

  Before and after the 4-week trial

• Pittsburgh sleep quality index

  Before and after the 4-week trial

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants need to drink honey every day for four weeks.

Dietary Supplement: Honey

Control group

PLACEBO COMPARATOR

Participants need to drink water every day for four weeks.

Dietary Supplement: Water

Interventions

Honey DIETARY_SUPPLEMENT

Participants need to drink honey every day for four weeks.

Experimental group

Water DIETARY_SUPPLEMENT

Participants need to drink water every day for four weeks.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the cessation clinic patients aged more than 18
• only take Champix for smoking cessation

You may not qualify if:

• diabetes, cancer, renal disease
• with wet and hot body constitution
• allergic to honey
• accepting traditional Chinese medicine intervention

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Substance Withdrawal Syndrome

Interventions

Honey; Water

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Chung-shan Hung, Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 3, 2022
• Study Start: September 3, 2021
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2023
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

TW (1)