Official Title
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
Brief Summary

Chinese medicine has been used for thousands of years in the treatment of epidemic diseases. Through the long-term struggle with the epidemic, Investigators have accumulated and explored a lot of prevention and control experience. According to recent reports, Chinese medicine plays an important role in the treatment of COVID-19. For example. Therefore, it is of great clinical significance to further develop the prevention of COVID-19 by Chinese medicine. According to the 《Diagnosis and treatment of COVID-19》published by National Health Committee and the experience of professional TCM physician, although the disease is generally susceptible, individuals with the body constitution of "deficiency of Qi and Yang" and "deficiency of Qi and Yin" are more prefer to suffer from COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing COVID-19. Therefore, "Invigorating Qi and Yang, invigorating qi and Yin" can be regarded as the primary strategy of preventing COVID-19 in Chinese medicine. After a series of questionnaire surveys and blood sample collection, investigators can estimate subjects with body constitution is more likely to infect COVID-19.

Detailed Description

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.
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. 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. 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, investigators 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. 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. 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". 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. 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. 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, investigators can identify the subjects with "Deficiency of Qi and
Yang " or "Deficiency of Qi and Yin". 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 Self-test for
classification and judgment of body constitution by 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
COVID-19》issued by the National Health Commission, 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.

Unknown status
COVID19
Herbal Medicine

Drug: Yu-Ping-Feng formula

Yu-Ping-Feng formula produced by PuraPharm International (H.K) Ltd is a registered Chinese medicine formula by Chinese Medicine Council of Hong Kong (registration number: HKC-08255). The intake dosage is 5g twice daily.

Drug: Xiang-Sha-Liu-Jun formula

Xiang-Sha-Liu-Jun formula produced by PuraPharm International (H.K) Ltd is a registered Chinese medicine formula by Chinese Medicine Council of Hong Kong (registration number: HKC-08252). The intake dosage is 5g twice daily.

Drug: Liu-Wei-Di-Huang formula

Liu-Wei-Di-Huang formula produced by PuraPharm International (H.K) Ltd is a registered Chinese medicine formula by Chinese Medicine Council of Hong Kong (registration number: HKC-08273). The intake dosage is 5g twice daily.

Drug: Placebo for "Deficiency of Qi and Yang"

Placebo for the group of "deficiency of Qi and Yang" is composed of 5% Yu-Ping-Feng formula+Xiang-Sha-Liu-Jun formula

Drug: Placebo for "Deficiency of Qi and Yin"

Placebo for the group of "deficiency of Qi and Yin" is composed of 5% Yu-Ping-Feng formula+Liu-Wei-Di-Huang formula

Eligibility Criteria

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°C 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hong Kong
Locations

The University of Hong Kong
Hong Kong, Hong Kong, China, Hong Kong

Investigator: Van Szeto
Contact: 852-39176475
vann@hku.hk

Contacts

Cheng Zhang, Mphil
852-9202 2545
zttc@hku.hk

Yibin Feng, PhD, Principal Investigator
School of Chinese Medicine, The University of Hong Kong

The University of Hong Kong
NCT Number
Keywords
COVID19 Prevention
Chinese medicine
MeSH Terms
COVID-19