Chinese herbal tea to enhance stopping smoking

ISRCTN	ISRCTN16358150
DOI	https://doi.org/10.1186/ISRCTN16358150
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Beijing University of Chinese Medicine
Funder	Beijng University of Chinese medicine

Submission date: 18/12/2021
Registration date: 21/12/2021
Last edited: 31/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
It is known that stopping smoking can help prevent many diseases and save lives. It’s difficult to stop smoking and resist nicotine dependence. Traditional Chinese herbal can help relieve cough and tea, as the routine behaviour can remind of stopping smoking. Thus, this study aims to find whether Chinese herbal tea can help smoking cessation and strengthen the faith in stopping smoking.

Who can participate?
Patients are willing to seek treatment to stop smoking in a smoking cessation clinic in China.

What does the study involve?
Participants will be randomly allocated to one of two groups as conventional treatment or combination with Chinese herbal tea for 4 weeks. After 4 weeks, participants will have the right to choose whether receive Chinese herbal tea for 8 weeks.
Participants will be asked to give blood samples at the beginning of the study and at the 4th week to ensure basic safety. Participants will get about 12-week treatment for smoking cessation and will complete the online questionnaires and assessments on the first day and every week to ensure the effectiveness of abstinence.

What are the possible benefits and risks of participating?
Participants will get 12-week treatment for smoking cessation and free Chinese herbal tea. Participants may suffer from nicotine withdrawal symptoms such as sick, dizziness.

Where is the study run from?
Beijing University of Chinese medicine and smoking cessation clinic of Beijing Chaoyang Hospital (China)

When is the study starting and how long is it expected to run for?
June 2021 to June 2022

Who is funding the study?
Beijing University of Chinese medicine (China)

Who is the main contact?
1. PhD. Chun-li Lu
Jennylu@bucme.edu.cn
2. Prof. Jian-ping Liu
Liujp@bucm.edu.cn

Contact information

Dr Chun-li Lu
Public

11 Bei San Huan Dong Lu Chaoyang District
Beijing
100029
China

ORCID ID	0000-0003-2939-1327
Phone	+86 15652387872
Email	Jennylu@bucm.edu.cn

Prof Jian-ping Liu
Principal investigator

11 Bei San Huan Dong Lu Chaoyang District
Beijing
100029
China

ORCID ID	0000-0002-0320-061X
Phone	+86 1064286760
Email	Liujp@bucm.edu.cn

Study information

Primary study design	Interventional
Study design	Single-centre interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of Chinese herbal tea combined with conventional therapy for patients to stopping smoking in smoking cessation clinic: a randomized controlled trial
Study acronym	CHESS
Study objectives	Chinese herbal tea can relieve the cough and heat syndrome (based on traditional Chinese medicine theory), thus Chinese herbal tea combined with conventional therapy may have superior effect for smoking cessation and increase the compliance of smokers to stop smoking.
Ethics approval(s)	Approved 12/06/2021, Ethics Committee of Beijing Chaoyang Hospital, Capital Medical University (8 Nan lu Workers Stadium, Chaoyang district, Beijing, China; +86 010-85231484; cyylunli2019@163.com), ref:2021-科-622
Health condition(s) or problem(s) studied	Treatment for patients who are willing to stop smoking in smoking cessation clinic
Intervention	Experimental group: Chinese herbal tea combined with conventional therapy (based on physician prescription) for 4 weeks. Control group: conventional therapy (based on physician prescription) for 4 weeks. After 4-week treatment, all participants can choose by their own will to receive which treatment for 8 weeks, we conduct the follow-up for these 8 weeks. Participants are randomly allocated to groups using the sealed envelope method.
Intervention type	Mixed
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2022

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Patients in smoking cessation clinic seeking treatment. 2. Patients eligible for conventional medication. 3. The patients voluntarily sign the informed consent.
Key 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.
Date of first enrolment	01/02/2022
Date of final enrolment	30/03/2022

Locations

Countries of recruitment

China

Study participating centre

Beijing Chaoyang Hospital, Capital Medical University

8 Nan lu Workers Stadium
Chaoyang district
Beijing
100020
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Jennylu@bucme.edu.cn)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	P15.06LB	25/04/2024	31/01/2025	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/01/2025: Publication reference added.
20/12/2021: Trial's existence confirmed by Chaoyang hospital.