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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 : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Professor FENG Yibin, The University of 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.

Condition or disease Intervention/treatment Phase
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

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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 : April 30, 2021
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)
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)
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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Kidney function biomarker, blood urea (dL/L), 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 blood urea before and after the treatment.

  7. Kidney function biomarker, creatinine in blood (μmol/L), 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 blood creatinine before and after the treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


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

Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong, China, Hong Kong, 999077
Contact: Van Szeto    852-39176475    vann@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yibin Feng, PhD School of Chinese Medicine, The University of Hong Kong
  Study Documents (Full-Text)

Documents provided by Professor FENG Yibin, The University of Hong Kong:
Study Protocol  [PDF] September 25, 2020
Informed Consent Form  [PDF] October 29, 2020

Publications of Results:
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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: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor FENG Yibin, The University of Hong Kong:
COVID19 Prevention
Chinese Medicine