Based on the Theory of "Body Constitution of Chinese Medicine" and "Combination of Prescription and Syndrome" to Improve COVID-19 Susceptible Body Constitution of Residents in Hong Kong
Phase: PHASE1
Conditions: COVID19, Herbal Medicine
Sponsor: The University of Hong Kong

Proposal for COVID-19 project 
(Study Protocol, Version no.6 dated 2020.09.25) 
 
Topic: Based on the theory of “body constitution of Chinese Medicine” and “combination of 
prescription and syndrome” to improve COVID-19 susceptible body constitution of residents in 
Hong Kong 
 
Researchers: Feng Yibin (PI), Wang Ning, Lai Yuen Kwan Agnes, Cheng Chien-shan, Zhang Cheng, 
Li Sha 
 
Catalogue 
1. Background and General information 
2. Research background 
3. Research objectives 
4. Experimental design 
5. Criteria for inclusion, exclusion and re-inclusion of subjects 
6. Treatment of subjects 
7. Efficacy evaluation 
8. Safety assessment 
9. Data collection and management 
10. Quality control and quality assurance 
11. Medical ethics 
12. Data processing and record keeping 
13. Publishing policy 
14. Supplementary materials (expected results / risk control) 
 
 
General information 
a. Title: Evaluating the effects of Chinese medicine in the prevention of COVID-19 in Hong Kong 
b. Sponsor: Chinese Medicine Development Fund, HK (accepted project) 
 
c. Project PI: Feng Yibin 
Title: Acting director, School of Chinese Medicine, the University of Hong Kong 
Tel: (852) 3917 6482 
Email: yfeng@hku.hk 
Address: G/F, School of Chinese Medicine, 10 Sassoon Road, Pokfulam, Hong Kong 
 
d. Researcher: Wang Ning 
Project task: Data Processing 
Title: Assistant Professor, School of Chinese Medicine, the University of Hong Kong 
Tel: (852) 3917 6441 
Address: G/F, School of Chinese Medicine, 10 Sassoon Road, Pokfulam, Hong Kong 
 
Researcher: Lai Yuen Kwan Agnes 

Project task: clinical data acquisition and expert advice 
Title: Assistant Professor, School of Nursing, the University of Hong Kong 
Tel: (852) 3917 6328 
Address: School of Nursing, the University of Hong Kong, 21 Sassoon Road, Pokfulam, Hong Kong 
 
Researcher: Cheng Chien-shan 
Project task: clinical data acquisition and analysis 
Position: Research Assistant, School of Chinese Medicine, the University of Hong Kong 
Tel: (852) 3917 6456 
Address: G/F, School of Chinese Medicine, 10 Sassoon Road, Pokfulam, Hong Kong 
 
Researcher: Zhang Cheng 
Project task: clinical data acquisition and analysis 
Position: Ph.D. candidate, School of Chinese Medicine, the University of Hong Kong 
Tel: (852) 3917 6456 
Address: G/F, School of Chinese Medicine, 10 Sassoon Road, Pokfulam, Hong Kong 
 
Researcher: Li Sha 
Project task: clinical data acquisition and analysis 
Post-doctoral researcher, School of Chinese Medicine, the University of Hong Kong 
Tel: (852) 3917 6456 
Address: G/F, School of Chinese Medicine, 10 Sassoon Road, Pokfulam, Hong Kong 
 
e: Relevant medical treatment at the clinical trial site: 
Researcher: Lai Yuen Kwan Agnes, Zhang Cheng, Cheng Chien-shan. Li Sha 
 
f: Names and addresses of clinical laboratories and other medical and / or technical laboratories: 
Relevant research will be carried out in the Central or Sassoon clinic, School of Chinese Medicine, 
the University of Hong Kong 
Central Clinic address: Room 703, 9 Queen's Road Central, Hong Kong 
Sassoon clinic address: G/F, School of Chinese Medicine, 10 Sassoon Road, Pokfulam, Hong Kong 
 
2. Research background: 
In December 2019, COVID-19 has been outbreaks in a series regions of China and abroad. Its 
pathogen was initially identified as a new coronavirus with single strand positive RNA [1]. COVID-
19 is considered to be a coronavirus associated with severe acute respiratory syndrome (SARS) and 
Middle East respiratory syndrome (MERS), which can affect the lower respiratory tract and 
manifest as pneumonia [2,3]. On January 31, 2020, the World Health Organization (WHO) officially 
announced that COVID-19 has become a "public health emergency of international concern" 
Although most provinces in China have inhibited the spread of COVID-19 after taking protective 
measures, the number of patients worldwide is still on the rise. According to WHO and recent 
reports, On 1st Sept, 2020, the total number of clinically confirmed cases in the world is 25327098, 
and the current total number in China is 90402 [4] China has incorporated COVID-19 into the class 
B infectious diseases in the law on the prevention and control of infectious diseases. Notably, it 

adopted the prevention and control of class A infectious diseases. It is worth noting that residents of 
Hong Kong have also been seriously infected with COVID-19. According to the latest report 
released by the Department of Health in Hong Kong, the total number of patients with COVID-19 
had risen to 4823 on Sept 1st, 2020. Therefore, it is very urgent to find effective control methods. 
According to the theory of Chinese medicine, COVID-19 belongs to the category of 
"epidemic toxin". TCM has been used for thousands of years in the treatment of epidemic diseases. 
Through the long-term struggle with the epidemic, we have accumulated a lot of experience for the 
pathogenesis, transmission, prevention and control of the epidemic. In mainland China, TCM plays 
an important role in the treatment of COVID-19. The recent retrospective analysis of 52 cases by 
Zhang Boli's research group showed that 34 cases in the treatment group of integrated TCM and 
Western medicine were superior to 18 cases in the simple western medicine group in terms of 
various bio-indexes, including clinical symptoms disappearance, the time of body temperature 
recovery, the average length of stay in hospital, the score of TCM Syndrome Scale, the rate of CT 
image improvement, the rate of clinical cure, and the conversion from common type to severe type 
[5]. According to a case study of 799 people in Hunan Provincial Administration of traditional 
Chinese medicine, the average length of stay in hospital of integrated traditional Chinese and 
Western medicine treatment is 2 days shorter than that of Western medicine treatment alone, and the 
number of patients with obvious improvement of symptoms accounts for 64% of the total number 
of observation [6]. For the modern measures of epidemic prevention, it includes three approaches: 
cutting off pathogens, controlling transmission routes, and reducing susceptible populations. 
However, so far, the preventive measures of Chinese medicine for COVID-19 has not been included 
in the medical system of Hong Kong, although it is widely authorized and promoted in mainland 
China. Therefore, it is of great clinical significance to further develop the prevention of COVID-19 
by Chinese medicine for reducing susceptible populations. The National Health Committee and 
the State Administration of TCM organized relevant experts to establish COVID-19 standardized 
diagnosis and treatment program. The updated diagnosis and treatment program describes the 
relationship between the dialectical classification of Chinese medicine and the stage of Western 
medicine. The pathogenesis of TCM can be summarized as "dampness, heat, toxin, blood stasis, 
deficiency" [7]. According to the statement of Tong Xiaolin, COVID-19 belongs to "cold dampness 
epidemic", which is caused by cold dampness epidemic virus. The disease is mainly caused by the 
deficiency of either yin or Yang [8]. According to a report on the clinical epidemiology of COVID-
19 published by Lancet, the median susceptible population of COVID-19 is 49 years old 
(interquartile range is 41-58 years old), which means the majority of patients are middle-aged and 
elderly [9]. The body constitution of this kind of patients is mainly divided into " Deficiency of Qi 
and Yang " and "Deficiency of Qi and Yin". However, so far, the prevention of treatment of COVID-
19 with TCM has not been included in the medical system of Hong Kong, although TCM therapy 
is widely authorized and promoted in mainland China. Therefore, It may be beneficial to provide 
TCM preventive measures to COVID-19 in Hong Kong. By using “Self-test for classification and 
judgment of body constitution by TCM theory” issued by Professor Wang Qi, a honorary Professor 
of School of Chinese medicine, the University of Hong Kong, we can identify the subjects with 
“Deficiency of Qi and Yang " or "Deficiency of Qi and Yin" [10]. According to the above-
mentioned pathogenesis characteristics of COVID-19 in the prevention stage, "Invigorating Qi and 
Yang, invigorating Qi and Yin" may be conducted by TCM treatment. The changes of body 
constitution will be measured by questionnaires before and after TCM intervention, including scale 

of self-test for classification and judgment of body constitution by Traditional Chinese Medicine 
(TCM) theory, Questionnaire of TCM symptom, and Fatigue scale. 
In order to scientifically evaluate the preventive effect of TCM on COVID-19, it is very 
important to reveal the changes of COVID-19 related biochemical indexes before and after the 
intervention of TCM. According to the discussion on “Diagnosis and treatment of new coronavirus 
pneumonia (7th Edition)” issued by the National Health Commission of China, the following 
changes in biochemical indicators are closely related to the occurrence of COVID-19. Firstly, the 
decrease of leukocytes, lymphocytes, and bone marrow cells (including granulocytes, erythrocytes, 
and megakaryocytes) in blood routine examination; the increase of troponin and ESR. Secondly, the 
reduction of macrophages-related immune cells, such as monocyte. Thirdly, the increased index of 
liver function and cardiac function, including AST, ALT, and LDH. Fourthly, inflammation related 
factors, including IL-6 and C-reactive protein. Therefore, the analysis of the relationship model of 
TCM syndrome and molecular biological profiles can further provide a novel preventive mode for 
COVID-19. 
 
Reference 
[1] Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, et al. World Health Organization declares Global 
Emergency: A review of the 2019 Novel Coronavirus (COVID-19). Int J Surg. 2020. 
[2] Mahase E. Coronavirus covid-19 has killed more people than SARS and MERS combined, despite lower case 
fatality rate. BMJ. 2020;368:m641. 
[3] Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical Characteristics of Coronavirus Disease 2019 
in China. N Engl J Med. 2020. 
[4] http://www.nhc.gov.cn. 
[5]Xia Wenguang, An Changqing, Zheng Chanjuan, Zhang Jixian, Huang Min, Wang Yu, Yang Fengwen, Duan can, 
Li Zhengliang, Liu Qingquan, Zhang Boli. Clinical study on 34 cases of COVID19 patients by Integration of Chinese 
and Western Medicine. Journal of traditional Chinese medicine:1-7. 
[6] Huang Huiyong, Xiao Wenming, Wang Yingyi, Cai Hongkun, Chen Juan, Tan Hanyu. Analysis report of 
traditional Chinese medicine treatment for patients with new coronavirus pneumonia in Hunan Province [J/OL]. 
Journal of Hunan University of traditional Chinese medicine: 1-4 
[7] Huang xiongjie, Lai min, Jia Chunhua, Liu Wei. Traditional Chinese medicine in the world: 2020, 1-6 
[8]ong Xiaolin, Li Xiuyang, Zhao Linhua, Li Qingwei, Yang Yingying, Lin Yiqun, Ding Qiyou, Lei ye, Wang Qiang, 
song bin, Liu Wenke, Shen Shiwei, Zhu Xiangdong, Huang Feijian, Zhou Yide. Discussion on the prevention and 
treatment strategy of new coronavirus pneumonia (covid-19) from the perspective of "cold dampness epidemic" [J / 
OL]. Journal of traditional Chinese medicine: 1-6 
[9] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel 
coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. 
[10] Liu Yu, Wang Qi. Suggestions and analysis of standard revision of classification and judgment of constitution 
of traditional Chinese medicine [J]. Journal of Beijing University of traditional Chinese medicine, 2013,36 (05): 
300-304. 
 
2a. Table 1: The groups and expected COVID-19 preventive treatments: 
All the constructive and intake dose of formula are conducted by the standard criteria of Nong’s 
CM 
Constitution of Chinese 
Medicine 
Group 
Formula 

Deficiency of Qi and Yang: 
shortness 
of 
breath; 
Laziness, chilly limbs, self-
perspiration, sore waist and 
knees; light tongue, thin 
white moss, deep and fine 
pulse 
CM-induced invigorating of Qi 
and Yang (QYang-group) 
Yu-Ping-Feng and Xiang-Sha-Liu-
Jun formula (Nong’s CM) 
5g twice daily for each formula 
(20g in total per day) 
Placebo control of invigorating 
Qi and Yang (PQYang-group) 
The placebo is made of 5% herbal 
medicine of nourishing qi and 
yang 
10g twice daily per placebo 
(20g in total per day) 
Deficiency of Qi and Yin: 
tiredness and weakness, 
shortness of breath when 
moving; fear of heat, five 
heart hot, self-perspiration 
and 
night 
sweat; 
red 
tongue, thin white or light 
peeling, weak and fast 
pulse 
CM-induced invigorating of Qi 
and Yin (QYin-group) 
Yu-Ping-Feng and Liu-Wei-Di-
Huang formula (Nong’s CM) 
5g twice daily for each formula 
(20g in total per day) 
Placebo control of invigorating 
Qi and Yin (PQYin-group) 
The placebo is made of 5% herbal 
medicine for nourishing qi and yin 
10g twice daily per placebo 
(20g in total per day) 
 
2b. Summary of non-clinical research results that may have clinical significance. 
This project is based on the reference of clinical observation and research on the prevention of 
COVID-19 by the theory of “Body constitution of TCM" and "Combination of formula and 
syndrome". In the early stage, we have reviewed a large number of papers and Diagnosis and 
treatment of new coronavirus pneumonia (7th Edition) published by national health commission 
regarding the TCM-related prevention of COVID-19. Finally, according to the theoretical 
knowledge of TCM, we may classify the susceptible body constitution of COVID-19 into 
"deficiency of Qi and Yang" and "deficiency of Qi and Yin", which might be of great significance 
for COVID-19 prevention. 
 
2c. A summary of the known and potential risks and benefits, if any, of the subjects. 
Subjects will be divided into four groups, including QYang-group, PQYang-group, QYin-group, 
and PQYin-group. According to different syndrome types, our clinic will provide timely medical 
help. Under normal condition, our TCM formula will not have obvious adverse reactions to the 
subjects with deficiency of Qi with either Yang or Yin. Moreover, Nong’s Chinese Medicine is a 
renowned standardized production in Hong Kong. It has been in safety testing with specific intake 
dosage before it goes on the market. For the risk of specific TCM treatment, subjects with external 
self-perspiration, yin deficiency and night perspiration cannot use Yupingfeng formula, since it may 
aggravate the symptoms of sweating and yin deficiency. Subjects with dry mouth and tongue cannot 
use Xiangsha Liujun formula, because it may aggravate this symptom. Subjects without obvious 
deficiency of kidney yin should not take Liuwei Dihuang formula, because it will cause diarrhea 
and loss of appetite. We will exclude these kinds of subjects in this study. If subjects with fever, dry 
cough, fatigue, runny nose, sore throat, diarrhea and other side effects, we will terminate the clinical 
study of this subject and offer essential treatment for reducing the side effect. Meanwhile, we will 
report the situation to Hospital Authority during the current COVID-19 pandemic. 
 

2d. Route of administration, dosage, description and reason of the administration plan, and treatment 
cycle. 
The administration route of Chinese medicine in this project is oral. The dosage and prescription 
scheme are established according to Table 1. The treatment duration was one month. The TCM 
formulas in the above table were designed by the clinical TCM practitioners of the School of 
Chinese Medicine, the University of Hong Kong, which was based on the clinical experience and 
Diagnosis and treatment of new coronavirus pneumonia (7th Edition). All the intake doses are 
shown in Table 1, which is taken from the standardized production in Nong’s CM. 
 
2e. This clinical trial will strictly implement according to the GCP outline (https://en.wikipedia.org 
/wiki/ good_clinical_practice). 
 
2f. Description of the population to be studied. 
According to the contents described in the Diagnosis and treatment of new coronavirus pneumonia 
(7th Edition) and a Lancet study, the median age of the susceptible population is 49 years 
(interquartile range 41-58 years), and the majority of patients are middle-aged and elderly. The 
subjects characterized by "deficiency of Qi and Yang" and "deficiency of Qi and Yin" were regarded 
as the susceptible population. 
 
2g. Research relevant literature and data, and provide research background basis: 
The background of this study refers to Diagnosis and treatment of new coronavirus pneumonia (7th 
Edition) [1]. This project described the epidemiological characteristics of COVID-19 and the 
statements of "Combination of formula and Syndrome" with specific prescriptions. In this project, 
the design of formula and classification of susceptible individuals refer to “Diagnosis and treatment 
of new coronavirus pneumonia (7th Edition)”, studies from Lancet and New England Journal of 
Medicine [2-4]. In addition, Professor Wang Qi from School of Chinese Medicine, HKU, 
established the criteria for classification and determination of body constitution of Chinese medicine 
[5]. Moreover, Questionnaire of TCM symptom, and the Chalder fatigue scale will be adopted for 
providing a theoretical basis for the design and implementation of the clinical research of this project 
[6] 
 
References: 
[1] Diagnosis and treatment of new coronavirus pneumonia (7th Edition) http://www.gov.cn. 
[2] Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, et al. World Health Organization 
declares Global Emergency: A review of the 2019 Novel Coronavirus (COVID-19). Int J Surg. 2020. 
[3] Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical Characteristics of Coronavirus 
Disease 2019 in China. N Engl J Med. 2020. 
[4] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 
2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506.  
[5] Liu Xuan, Wang Qi. Suggestion and analysis of classification and constitution of traditional 
Chinese 
medicine 
[J]. 
Journal 
of 
Beijing 
University 
of 
traditional 
Chinese 
medicine,2013,36(05):300-304. 
[6] Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res 
2010;69:17-22. 10.1016/j.jpsychores.2009.10.007 

 
3. Research objectives: 
3a. Evaluation of the improvement of COVID19-related susceptible body constitution by TCM 
preventive treatment. 
3b. Clarify the distribution of COVID-19 susceptible residents in Hong Kong by questionnaires. 
3c. Identify the changes of biomarker which may be fluctuated by COVID19 infection according to 
“Diagnosis and treatment of new coronavirus pneumonia (7th Edition)” held by National Health 
Commission and State Administration of TCM. 
 
4. Experimental design: 
4a. Specific description of the time points to be measured during the test. 
There are two main time points in this clinical trial. The first is that one month after the TCM or 
placebo treatment as shown in Table 1, the subjects will receive both blood test and questionnaires, 
including “Self-test for classification and judgment of body constitution by TCM theory”, 
“Questionnaire of Chinese medicine symptom”, and Fatigue scale. According to the before-after 
changes of observation records in each questionnaire and blood test, the preventive effect of TCM 
was determined.  
 
4b. Test type, design description and schematic diagram of test phase. 
This study is a random, double-blind clinical research. All the subjects will be equally divided 
into TCM group (i.e. QYang-group, PQYang-group, QYin-group, and PQYin-group) and Placebo 
group for one-month specific treatment, which aims to investigate the preventive effect of TCM on 
the improvement of the body susceptibility to COVID-19. The study plan roadmap is shown below. 
 

4c. Describe the actions taken to avoid deviations. 
In order to reflect the objective reality of the experimental data as much as possible, we adopted 
a randomized double-blind clinical trial method. All subjects will be divided into four groups: 
QYang-group, PQYang-group, QYin-group, and PQYin-group. A total of 480 subjects were 
included. 
 
4d. Expected duration of subject participation, including follow-up (if any) 
The subjects of this project will last 1 month.  
 
4e. Description of "stop rule" or "stop criteria" for individual subjects. 
If the subjects have fever, dry cough, fatigue, runny nose, sore throat, diarrhea and other 
symptoms after taking the medicine, the subjects will immediately stop taking TCM or placebo. 
Meanwhile, subjects will give a certain degree of TCM clinical treatment. As these symptoms are 
similar to the epidemiological characteristics of the latent period of COVID-19, we will immediately 
report to HA in the current period of COVID-19 pandemic 
 
4f. Description of placebo control (if any) 
The placebo control group of this clinical trial is PQYang-group and PQYin-group. Their 
prescriptions are as follows: PQYang-group: the placebo is made of dextrin, bitterness agent, edible 
pigment, etc., and 5% herbal medicine of nourishing qi and yang; PQYin-group: the placebo is made 
of dextrin, bitterness agent, edible pigment, etc., and 5% herbal medicine for nourishing qi and yin. 
 
4g. Record and collection of clinical data. 
All clinical data will be recorded in the electronic versions.  
 
5. Criteria for inclusion, exclusion and re-inclusion of subjects 
Inclusion criteria: 
(1) Age 18 or above, regardless of gender; 
(2) For COVID-19 susceptible individuals, according to the criteria of “Self-test for classification 
and judgment of body constitution by TCM theory”, subjects with deficiency of Qi with either Yin 
or Yang will meet the inclusion criteria; 
(3) No previous allergy to traditional Chinese medicine; 
(4) Be able to understand Chinese questionnaire; 
(5) Willing to participate in the study. 
 
Exclusion criteria 
(1) Syndrome types are not related to "deficiency of Qi and Yang" and "deficiency of Qi and Yin"; 
(2) Suspected or confirmed COVID-19 patients; 
(3) Fever, body temperature > 37℃ with cough and other respiratory symptoms; 
(4) Those who have visited the epidemic area and have not completed isolation for 14 days after 
returning to Hong Kong 
 
Criteria for inclusion in the test after exclusion 
(1) If subjects quit in the middle of the trial due to their own wishes, but they wish to return to the 

clinical trial at certain time, we will investigate the subject again from the beginning of the trial. 
(2) Respiratory symptoms such as transient fever, dry cough, fatigue, runny nose and sore throat 
were excluded. Patients with the disappearance of respiratory symptoms after 14 days (excluding 
those with latent infection of COVID-19) can be re-included in this trial. 
 
6. Treatment of subjects 
We will treat the included subjects with TCMs or placebos in our study according to the details as 
shown in Table 1. In addition, all the steps of treatment are shown as below. 
 
7. Efficacy evaluation 
l 
Primary outcomes: 
Evaluation of the improvement of COVID19-related susceptible body constitution by TCM 
preventive treatment 
After the preventive intervention of Chinese Medicine, the COVID19-related susceptible body 
constitution (“deficiency of Qi and yang” or “deficiency of Qi and Yin”) may be improved, which 
will be measured by “Self-test for classification and judgment of body constitution by TCM theory”, 
Questionnaire of TCM symptom, and Fatigue scale. For the treatment, the combination of “Yu-
Ping-Feng formula” with either “Xiang-Sha-Liu-Jun formula” or “Liu-Wei-Di-Huang formula” will 
treat subjects with “deficiency of Qi and yang” or “deficiency of Qi and Yin” respectively. 
 
l 
Secondary outcomes: 
(1) Clarify the distribution of COVID-19 susceptible residents in Hong Kong by questionnaires 
(2) Identify the changes of biomarker which may be fluctuated by COVID19 infection according 
to “Diagnosis and treatment of new coronavirus pneumonia (7th Edition)” held by National Health 

Commission and State Administration of TCM. 
 
The included biochemical indicators are as follows: 
Blood routine: Complete Blood Count, Erythrocyte sedimentation rate 
Liver function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) 
Heart function: Lactate dehydrogenase (LDH), Troponin I 
Kidney function: Creatinine, Blood urea 
Inflammation and immune-related indicator: C-reactive protein, IL-6, CD4, and CD8 
 
Confirmation of medication process: 
We will make sure whether the subjects have taken the medicine or not through two methods, 
including patients' own record and return of the medicine package. 
 
8. Safety assessment 
For this study, the adverse event may be any adverse sign (including abnormal laboratory test 
results), which is related or not related to the treatment, including abdominal distention and pain, 
nausea, diarrhea, gastrointestinal disease, headache, etc. If the above-mentioned occurred during the 
treatment, the subjects will immediately stop taking TCM or placebo. We will provide the essential 
TCM clinical treatment to the subjects.  
 
9. Data collection and management 
The quantitative variables between two groups will be analyzed by student’s t test. In addition, if 
the comparative groups are more than two, Repeated measure ANOVA will be taken. The classified 
variables will be measured by chi square test. Through logistic regression and linear regression 
model, this paper will study the multi-factor analysis the data with P < 0.05 has statistical 
significance. The study leader will then decide whether to proceed with the trial based on the 
preliminary results and will report to the ethics committee.  
 
We will give a unique serial number to the scale answer and blood sample according to each 
questionnaire collected. EpiData 3.1 will be used for data logging. It is a program designed for data 
logging to prevent invalid input. The raw data will be kept for 5 years after the completion of the 
study, and destroyed afterwards unless an application to IRB for further retention is approved. 
Personal identifying information will be removed before statistical analysis. 
 
10. Quality control and quality assurance 
(1) Research assistants will be trained in an appropriate research method, focusing on maintaining 
research integrity, data confidentiality and data protection. 
(2) Data is randomly selected periodically for re-entry to determine accuracy. 
(3) The researchers in this study can be gathered as an experienced team of TCM practitioners and 
biomedical experts in the School of Chinese Medicine, the University of Hong Kong 
 

11. Medical ethics 
Subjects in the study is entirely voluntary. The subjects will be required to sign a consent form 
before participating in the study component of the project and questionnaire and interviews. All 
subjects will be provided with a contact telephone number in case they have any quires about the 
project, and be reassured that they have the right to withdraw at any time point without any 
consequences. 
 
12. Data processing and record keeping 
All the data will be processed in R or SPSS for statistical analysis. The raw data in paper format 
will be kept in a locked cabinet for 5 years. Meanwhile, all the data will input into EpiData 3.1 for 
5-year electronic storage after the completion of the study. All the information of subjects will be 
kept strictly confidential. 
 
13. Publishing policy 
The results of the study will publish at international conferences and peer-reviewed journals. All 
researchers involved in this study will have access to the final data. Subjects will be informed of the 
results of the study. 
 
14. Supplementary materials 
The scheme of risk control for COVID-19 infection is as follows 
1. Before entering the clinic, the subjects and the medical staff should take the temperature and 
ensure that the temperature is normal before carrying out the clinical trial.  
2. Since the subject may be a latent period patient of COVID-19. Therefore, the staff in the clinic 
must wear surgical masks and disinfect the clinic every 1-2 hours. 
3. When the subjects are in close face-to-face contact with the examiner (< 1m), the examiner shall 
wear N95 or equivalent masks and goggles. If necessary, medical staff can wear isolation clothing 
in special circumstances.