Treatment for patients who are willing to stop smoking in smoking cessation clinic Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Carbon monoxide expiratory volume is measured using Carbon monoxide detector at baseline, 1day, 4 weeks. 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. 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 2. Traditional Chinese medicine (TCM) syndrome is measured using TCM scale at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks. 3. Safety outcomes are measured using blood examination (ALT, AST, GGT, BUN, Cr, UA, biochemical electrolyte) at baseline and 4 weeks. 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. | — |
Countries
China