COVID19Phase 1/2NCT04668222
Changing Susceptible Body Constitution for COVID-19 Prevention by Chinese Medicine in Hong Kong Residents
A Phase 1/2 study testing Yu-Ping-Feng formula, Xiang-Sha-Liu-Jun formula and Liu-Wei-Di-Huang formula in people with COVID19 and Herbal Medicine, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19, Herbal Medicine
- What is being tested?
- Yu-Ping-Feng formula, Xiang-Sha-Liu-Jun formula and Liu-Wei-Di-Huang formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2021to 30 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or above, regardless of gender;
- 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;
- No previous allergy to traditional Chinese medicine;
- Be able to understand Chinese questionnaire;
- Willing to participate in the study.
Who cannot join
- Syndrome types are not related to "deficiency of Qi and Yang" and "deficiency of Qi and Yin";
- Suspected or confirmed COVID-19 patients;
- Fever, body temperature > 37°C with cough and other respiratory symptoms;
- Those who have visited the epidemic area and have not completed isolation for 14 days after returning to Hong Kong
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong
Hong Kong, Hong Kong, China, 999077
Van Szeto, 852-39176475, vann@hku.hk
About this study
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
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.
Read the 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.
- Conditions
- COVID19, Herbal Medicine
- Being tested
- Yu-Ping-Feng formula, Xiang-Sha-Liu-Jun formula, Liu-Wei-Di-Huang formula, Placebo for "Deficiency of Qi and Yang", Placebo for "Deficiency of Qi and Yin"
- Keywords
- COVID19 Prevention, Chinese Medicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yu-Ping-Feng formulaDrug
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.
Xiang-Sha-Liu-Jun formulaDrug
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.
Liu-Wei-Di-Huang formulaDrug
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.
Placebo for "Deficiency of Qi and Yang"Drug
Placebo for the group of "deficiency of Qi and Yang" is composed of 5% Yu-Ping-Feng formula+Xiang-Sha-Liu-Jun formula
Placebo for "Deficiency of Qi and Yin"Drug
Placebo for the group of "deficiency of Qi and Yin" is composed of 5% Yu-Ping-Feng formula+Liu-Wei-Di-Huang formula
| Study group | Role | What they receive |
|---|---|---|
| Deficiency of Qi and Yang (QYang-group) | Experimental | Participants will receive Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula) Receives: Drug: Yu-Ping-Feng formula; Drug: Xiang-Sha-Liu-Jun formula |
| Placebo control of invigorating Qi and Yang (PQYang-group) | Placebo comparator | The placebo is made of 5% Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula) Receives: Drug: Placebo for "Deficiency of Qi and Yang" |
| Deficiency of Qi and Yin (QYin-group) | Experimental | Participants will receive Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine Formula) Receives: Drug: Yu-Ping-Feng formula; Drug: Liu-Wei-Di-Huang formula |
| Placebo control of invigorating Qi and Yin (PQYin-group) | Placebo comparator | The placebo is made of 5% Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine Formula) Receives: Drug: Placebo for "Deficiency of Qi and Yin" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential COVID-19 susceptible body constitutions will be measured by the scale of "Self-test for classification and judgment of body constitution by traditional Chinese medicine (TCM) theory"
At the beginning of the clinical trial, the classification of body constitution will be determined by scale of "Self-test for classification and judgment of body constitution by Traditional Chinese Medicine (TCM) theory", in which 8 kinds of body constitutions are involved, including the potential COVID-19 susceptible body constitution "deficiency of Qi with either Yang and Yin". There are 9 types of body constitution and 7 choices for each body constitution. The minimun and maximum score for each body constitution is 7 and 35, respectively. The total score of this scale is 315. Higer score in a specific item stands for the stonger correlation with a specific body constitution.
Measured: 1 month
Changes of TCM-based syndromes will be measured by the "Questionnaire of TCM symptom"
The scale of "Questionnaire of Traditional Chinese Medicine (TCM) symptom" will be used to measure the changes of TCM specific symtom before and after the treatment, such as the changes of "Irritable motion" and " insomnia". The scale of "Questionnaire of TCM symptom" consists of 20 items and each item has 4 choices. The minimun and maximum score for each body is 1 and 4, respectively. The total score of this scale is 80. Higer score in a specific item represents the stonger correlation with a specific TCM symptom
Measured: 1 month
Potential changes of fatigue status will be measured by Fatigue Scale
The fatigue scale is a 13-item scale of fatigue status. Items are scored on a 0 to 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the fatigue, all items are summed to create a single fatigue score ranging from 0 to 52. Higer score stands for a stonger correlation with fatigue.
Measured: 1 month
Secondary outcomes (7)
Complete Blood Count will be measured by Automated Cell Counter
According to the "Diagnosis and treatment of new coronavirus pneumonia (7th Edition)" published by National Health Commission of China, the investigators will measure the potential COVID19-fluctuated Complete Blood Count (red blood cells, white blood cells, and platelets), before and after the treatment.
Measured: 1 month
Liver function biomarkers in blood will be measured by Automatic Blood Biochemistry Analyzer
In terms of the "Diagnosis and treatment of new coronavirus pneumonia (7th Edition)", the investigators will further test the potential COVID19-fluctuated liver biomarkers by Automatic Blood Biochemistry Analyzer, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT), before and after the treatment.
Measured: 1 month
Heart function biomarkers in blood will be measured by Automatic Blood Biochemistry
According to the "Diagnosis and treatment of new coronavirus pneumonia (7th Edition)", the investigators will further test the potential COVID19-fluctuated heart biomarkers by Automatic Blood Biochemistry Analyzer, including lactate dehydrogenase (LDH), troponin I,before and after the treatment.
Measured: 1 month
Inflammatory biomarker in blood will be measured by Automatic Blood Biochemistry
In accordance with the "Diagnosis and treatment of new coronavirus pneumonia (7th Edition)", the investigators will measure the inflammatory biomarker IL-6 by Automatic Blood Biochemistry, which is widely involved in the pathogenesis of several inflammations.
Measured: 1 month
The changes of quantification of blood CD4 and CD8 populations will be measured by flow cytometric analyzer
For futher analyzing the potential COVID19-fluctuated immuno-markers, the investigators will measure the population of CD4, CD8, and CD4/CD8 ratio in the blood by flow cytometric analyzers. The biomarkers of CD4 and CD8 will be used to stain the blood cells followed by the detection of its populations.
Measured: 1 month
Kidney function biomarker, blood urea (dL/L), will be measured by Automatic Blood Biochemistry
According to the "Diagnosis and treatment of new coronavirus pneumonia (7th Edition)", the investigators will further test the potential COVID19-fluctuated kidney biomarkers by Automatic Blood Biochemistry Analyzer, including blood urea before and after the treatment.
Measured: 1 month
Kidney function biomarker, creatinine in blood (μmol/L), will be measured by Automatic Blood Biochemistry
According to the "Diagnosis and treatment of new coronavirus pneumonia (7th Edition)", the investigators will further test the potential COVID19-fluctuated kidney biomarkers by Automatic Blood Biochemistry Analyzer, including blood creatinine before and after the treatment.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start30 Apr 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to the assessment of "Self-test for classification and judgment of body constitution by TCM theory", participants with the body constitution of "deficiency of Qi and Yin" or "deficiency of Qi and Yin" will be included into this study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor FENG Yibin, The University of Hong Kong
- Investigators
- Yibin Feng, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668222
- Sponsor's protocol ID
- UW20-480
- Status last verified
- Apr 2021
- First submitted
- 30 Nov 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26.
PubMed 32112977Mahase E. Coronavirus covid-19 has killed more people than SARS and MERS combined, despite lower case fatality rate. BMJ. 2020 Feb 18;368:m641. doi: 10.1136/bmj.m641. No abstract available.
PubMed 32071063Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chen G, Zhang C, Li S, Yang Q, Gao Y, He N, Tang G, Qian X, Zhou H, Feng Y. A randomized controlled trial protocol of herbal formulas for modifying susceptible body constitution to enhance COVID-19 resistance in Hong Kong residents. J Thorac Dis. 2026 Jul 31;18(7):808. doi: 10.21037/jtd-2025-aw-2423. Epub 2026 Jun 23.
PubMed 42583117
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04668222
- Acronym / sponsor ID
- UW20-480
- Conditions
- COVID19, Herbal Medicine
- Keywords
- COVID19 Prevention, Chinese Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- According to the assessment of "Self-test for classification and judgment of body constitution by TCM theory", participants with the body constitution of "deficiency of Qi and Yin" or "deficiency of Qi and Yin" will be included into this study.
| Arm | Type | Receives |
|---|---|---|
| Deficiency of Qi and Yang (QYang-group) | Experimental | Drug: Yu-Ping-Feng formula, Drug: Xiang-Sha-Liu-Jun formulaParticipants will receive Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula) |
| Placebo control of invigorating Qi and Yang (PQYang-group) | Placebo comparator | Drug: Placebo for "Deficiency of Qi and Yang"The placebo is made of 5% Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula) |
| Deficiency of Qi and Yin (QYin-group) | Experimental | Drug: Yu-Ping-Feng formula, Drug: Liu-Wei-Di-Huang formulaParticipants will receive Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine Formula) |
| Placebo control of invigorating Qi and Yin (PQYin-group) | Placebo comparator | Drug: Placebo for "Deficiency of Qi and Yin"The placebo is made of 5% Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine Formula) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or above, regardless of gender;
- 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;
- No previous allergy to traditional Chinese medicine;
- Be able to understand Chinese questionnaire;
- Willing to participate in the study.
Key exclusion criteria (4 listed)
- Syndrome types are not related to "deficiency of Qi and Yang" and "deficiency of Qi and Yin";
- Suspected or confirmed COVID-19 patients;
- Fever, body temperature > 37°C with cough and other respiratory symptoms;
- Those who have visited the epidemic area and have not completed isolation for 14 days after returning to Hong Kong
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yu-Ping-Feng formulaYu-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 | Deficiency of Qi and Yang (QYang-group), Deficiency of Qi and Yin (QYin-group) |
| Xiang-Sha-Liu-Jun formulaXiang-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 | Deficiency of Qi and Yang (QYang-group) |
| Liu-Wei-Di-Huang formulaLiu-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 | Deficiency of Qi and Yin (QYin-group) |
| 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 control of invigorating Qi and Yang (PQYang-group) |
| 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 | Drug | Placebo control of invigorating Qi and Yin (PQYin-group) |
Primary outcome
Potential COVID-19 susceptible body constitutions will be measured by the scale of "Self-test for classification and judgment of body constitution by traditional Chinese medicine (TCM) theory"
Time frame: 1 month
At the beginning of the clinical trial, the classification of body constitution will be determined by scale of "Self-test for classification and judgment of body constitution by Traditional Chinese Medicine (TCM) theory", in which 8 kinds of body constitutions are involved, including the potential COVID-19 susceptible body constitution "deficiency of Qi with either Yang and Yin". There are 9 types of body constitution and 7 choices for each body constitution. The minimun and maximum score for each body constitution is 7 and 35, respectively. The total score of this scale is 315. Higer score in a specific item stands for the stonger correlation with a specific body constitution.
Changes of TCM-based syndromes will be measured by the "Questionnaire of TCM symptom"
Time frame: 1 month
The scale of "Questionnaire of Traditional Chinese Medicine (TCM) symptom" will be used to measure the changes of TCM specific symtom before and after the treatment, such as the changes of "Irritable motion" and " insomnia". The scale of "Questionnaire of TCM symptom" consists of 20 items and each item has 4 choices. The minimun and maximum score for each body is 1 and 4, respectively. The total score of this scale is 80. Higer score in a specific item represents the stonger correlation with a specific TCM symptom
Potential changes of fatigue status will be measured by Fatigue Scale
Time frame: 1 month
The fatigue scale is a 13-item scale of fatigue status. Items are scored on a 0 to 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the fatigue, all items are summed to create a single fatigue score ranging from 0 to 52. Higer score stands for a stonger correlation with fatigue.
7 secondary outcomes
Complete Blood Count will be measured by Automated Cell Counter
Time frame: 1 month
Liver function biomarkers in blood will be measured by Automatic Blood Biochemistry Analyzer
Time frame: 1 month
Heart function biomarkers in blood will be measured by Automatic Blood Biochemistry
Time frame: 1 month
Inflammatory biomarker in blood will be measured by Automatic Blood Biochemistry
Time frame: 1 month
The changes of quantification of blood CD4 and CD8 populations will be measured by flow cytometric analyzer
Time frame: 1 month
Kidney function biomarker, blood urea (dL/L), will be measured by Automatic Blood Biochemistry
Time frame: 1 month
Kidney function biomarker, creatinine in blood (μmol/L), will be measured by Automatic Blood Biochemistry
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Results publication: PubMed 32112977Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26.
- Results publication: PubMed 32071063Mahase E. Coronavirus covid-19 has killed more people than SARS and MERS combined, despite lower case fatality rate. BMJ. 2020 Feb 18;368:m641. doi: 10.1136/bmj.m641. No abstract available.
- Results publication: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Results publication: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Derived from this study: PubMed 42583117Chen G, Zhang C, Li S, Yang Q, Gao Y, He N, Tang G, Qian X, Zhou H, Feng Y. A randomized controlled trial protocol of herbal formulas for modifying susceptible body constitution to enhance COVID-19 resistance in Hong Kong residents. J Thorac Dis. 2026 Jul 31;18(7):808. doi: 10.21037/jtd-2025-aw-2423. Epub 2026 Jun 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yibin Feng, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Yu-Ping-Feng formula, Xiang-Sha-Liu-Jun formula and Liu-Wei-Di-Huang formula in people with COVID19 and Herbal Medicine, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Zhang, Mphil (852-9202 2545, zttc@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential COVID-19 susceptible body constitutions will be measured by the scale of "Self-test for classification and judgment of body constitution by traditional Chinese medicine (TCM) theory" (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04668222, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.