Chinese herbal tea to enhance stopping smoking

Not Applicable

• Conditions: Treatment for patients who are willing to stop smoking in smoking cessation clinic; Not Applicable

• Registration Number: ISRCTN16358150
• Lead Sponsor: Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-21
• Last Update Posted: 4 January 2022
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients in smoking cessation clinic seeking treatment.
2. Patients eligible for conventional medication.
3. The patients voluntarily sign the informed consent.

Exclusion Criteria

1. Patients with serious diseases of the heart, lung, kidney and hematopoietic system.
2. Pregnant or lactating women.
3. Patients who are participating in other clinical trials.
4. Patients allergic to licorice and platycodon grandiflorum.
5. Patients with allergies to smoking cessation medications or similar ingredients.
6. Patients who are receiving other TCM treatments and whose TCM prescriptions include Gansui, Jingdaji, Haizao, and Yuanhua.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Carbon monoxide expiratory volume is measured using Carbon monoxide detector at baseline, 1day, 4 weeks.<br> 2. Abstinence rate is measured using patients’ self-report at baseline, 1 day, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks.<br> 3. Nicotine dependence is measured using Fagerstrom test for nicotine dependence (FTND) at baseline, 1 day, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks.<br> 4. Implementation outcomes of combined Chinese herbal tea during smoking cessation treatment is measured using questionnaire and interview (containing acceptability, appropriateness, feasibility, adoption, fidelity, and sustainability) at baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Nicotine withdrawal symptoms are measured using Minnesota Nicotine Withdrawal Scale (MNWS) at baseline, 1 day, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks.<br> 2. Traditional Chinese medicine (TCM) syndrome is measured using TCM scale at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks.<br> 3. Safety outcomes are measured using blood examination (ALT, AST, GGT, BUN, Cr, UA, biochemical electrolyte) at baseline and 4 weeks.<br> 4. Adverse events are measured using patients’ self-report at 1 day, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks during the whole course of study.<br>