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
Sponsor study identifier
interventional
480
1 country
1
Study Start
April 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2020
Actual (reported)December 16, 2020
Actual (reported)April 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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
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.
1 month
Complete Blood Count will be measured by Automated Cell Counter
1 month
Liver function biomarkers in blood will be measured by Automatic Blood Biochemistry Analyzer
1 month
Heart function biomarkers in blood will be measured by Automatic Blood Biochemistry
1 month
Inflammatory biomarker in blood will be measured by Automatic Blood Biochemistry
1 month
The changes of quantification of blood CD4 and CD8 populations will be measured by flow cytometric analyzer
1 month
Participants will receive Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula)
The placebo is made of 5% Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine 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.
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.
The University of Hong Kong
Hong Kong, Hong Kong, China, 999077, Hong Kong
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.
Mahase 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.
Yibin Feng, PhD
The University of Hong Kong
First Submitted
November 30, 2020
First Posted
December 16, 2020
Study Start
April 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Abatacept for Patients With COVID-19 and Respiratory Distress
Participants will receive Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine Formula)
The placebo is made of 5% Yu-Ping-Feng and Liu-Wei-Di-Huang formula (Chinese Medicine 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 for the group of "deficiency of Qi and Yang" is composed of 5% Yu-Ping-Feng formula+Xiang-Sha-Liu-Jun formula
Placebo for the group of "deficiency of Qi and Yin" is composed of 5% Yu-Ping-Feng formula+Liu-Wei-Di-Huang formula
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Guan 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.
Huang 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.
Chen 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.
Primary Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 28, 2021
Record last verified: 2021-04
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