Changing Susceptible Body Constitution for COVID-19 Prevention by Chinese Medicine in Hong Kong Residents
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ClinicalTrials.gov Identifier: NCT04668222 |
Recruitment Status :
Not yet recruiting
First Posted : December 16, 2020
Last Update Posted : December 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID19 Herbal Medicine | Drug: Yu-Ping-Feng formula Drug: Xiang-Sha-Liu-Jun formula Drug: Liu-Wei-Di-Huang formula Drug: Placebo for "Deficiency of Qi and Yang" Drug: Placebo for "Deficiency of Qi and Yin" | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 480 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Estimated Study Start Date : | December 15, 2020 |
Estimated Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | November 30, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Deficiency of Qi and Yang (QYang-group)
Participants will receive Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula)
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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. |
Placebo Comparator: Placebo control of invigorating Qi and Yang (PQYang-group)
The placebo is made of 5% Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula)
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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 |
Experimental: Deficiency of Qi and Yin (QYin-group)
Participants will receive Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine Formula)
|
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: 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. |
Placebo Comparator: Placebo control of invigorating Qi and Yin (PQYin-group)
The placebo is made of 5% Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine 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 |
- 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.
- Complete Blood Count will be measured by Automated Cell Counter [ Time Frame: 1 month ]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.
- Liver function biomarkers in blood will be measured by Automatic Blood Biochemistry Analyzer [ Time Frame: 1 month ]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.
- Heart function biomarkers in blood will be measured by Automatic Blood Biochemistry [ Time Frame: 1 month ]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.
- Kidney function biomarkers in blood will be measured by Automatic Blood Biochemistry [ Time Frame: 1 month ]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 creatinine and blood urea, before and after the treatment.
- Inflammatory biomarker in blood will be measured by Automatic Blood Biochemistry [ Time Frame: 1 month ]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.
- The changes of quantification of blood CD4 and CD8 populations will be measured by flow cytometric analyzer [ Time Frame: 1 month ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668222
Contact: Cheng Zhang, Mphil | 852-9202 2545 | zttc@hku.hk |
Hong Kong | |
The University of Hong Kong | |
Hong Kong, Hong Kong, China, Hong Kong, 999077 | |
Contact: Van Szeto 852-39176475 vann@hku.hk |
Principal Investigator: | Yibin Feng, PhD | School of Chinese Medicine, The University of Hong Kong |
Documents provided by Professor FENG Yibin, The University of Hong Kong:
Responsible Party: | Professor FENG Yibin, Professor Feng Yibin, The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT04668222 |
Other Study ID Numbers: |
UW20-480 |
First Posted: | December 16, 2020 Key Record Dates |
Last Update Posted: | December 19, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID19 Prevention Chinese Medicine |