Changing Susceptible Body Constitution for COVID-19 Prevention by Chinese Medicine in Hong Kong Residents

NCT04668222 | Unknown Phase 1 DMC

• 1 other identifier: UW20-480
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19; Herbal Medicine

Keywords

COVID19 Prevention; Chinese Medicine

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• 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

Study Arms (4)

Deficiency of Qi and Yang (QYang-group)

EXPERIMENTAL

Participants will receive Yu-Ping-Feng and Xiang-Sha-Liu-Jun formula (Chinese Medicine Formula)

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)

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)

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)

Drug: Placebo for "Deficiency of Qi and Yin"

Interventions

Yu-Ping-Feng formula DRUG

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.

Deficiency of Qi and Yang (QYang-group); Deficiency of Qi and Yin (QYin-group)

Xiang-Sha-Liu-Jun formula DRUG

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.

Deficiency of Qi and Yang (QYang-group)

Liu-Wei-Di-Huang formula DRUG

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.

Deficiency of Qi and Yin (QYin-group)

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 control of invigorating Qi and Yang (PQYang-group)

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

Placebo control of invigorating Qi and Yin (PQYin-group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above, regardless of gender;
• No previous allergy to traditional Chinese medicine;
• Be able to understand Chinese questionnaire;
• Willing to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, China, 999077, Hong Kong

Location

Related Publications (4)

• 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.

  PMID: 32112977 RESULT

• 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.

  PMID: 32071063 RESULT

• 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.

  PMID: 32109013 RESULT

• 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.

  PMID: 31986264 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yibin Feng, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Zhang, Mphil

CONTACT

852-9202 2545; zttc@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Feng Yibin

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 16, 2020
• Study Start: April 30, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

HK (1)