Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients

NCT ID: NCT04544605

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2021-12-31

Brief Summary

According to the ongoing observational studies and the Chinese Medicine practice guideline for COVID-19 patients, the discharged patients with COVID-19 still exhibits certain clinical symptoms such as fatigue, poor appetite, short of breath, palpation, and poor sleep, which could be recognized as two main Patterns in Chinese Medicine, Qi Deficiency of Lung and Spleen and Qi & Yin Deficiency. Based on this, pulmonary rehabilitation to improve lung function upon discharged was proposed. Therefore, even patients with COVID-19 were discharged from hospitals, there are symptoms with significant clinical syndromes in Chinese Medicine perspectives. These symptoms, in terms of syndrome, which could link with the body constitutions, could be due to pre-COVID-19 infection, suffering from infection, or a consequence of post-infection.

This observational study is a rehabilitation programme to elucidate i) whether body constitution is linking with the infection of COVID-19; ii) whether TCM can help the recovery of discharged COVID-19 patients.

Detailed Description

This is an observational multi-centered study that will be conducted in the government subsidized tri-partite CM out-patient clinics (Chinese Medicine Clinic cum Training and Research Centres, "CMCTRs").

The study contains two parts as follows:

1. Retrospective Syndrome Survey: Retrospective information will be collected from participants using semi-structured interview and measuring the baseline body constitution before the rehabilitation treatment under the Programme, with the self-developed Body Constitutions Questionnaire.

2. TCM therapeutic assessment: The improvement of clinical symptoms and the status of body constitutions will be periodically evaluated.

Clinical CM Diagnostic Pattern & clinical characteristics assessments, lung function tests, quality of life and no. of western medical consultations will be assessed at each visit for 9 months. Both retrospective and prospective assessments will be done for those participants who have already joined the Rehabilitation Program in CMCTRs.

Sample Size: Estimated at 150 participants.

Treatment of the Rehabilitation Program in CMCTRs:

The treatment is based on individual Chinese Medicine syndrome and clinical symptoms based on the Chinese Medicine practice guideline for COVID-19 patients. Two main Chinese medicine syndromes for patients recovered from COVID-19 with the recommended prescriptions will be included in the Rehabilitation Program.

the participants will receive three months individualized-Chinese herbal medicine treatment in CMCTRs. After the three months treatment, they are free to either continue another three-month treatment or enter into the follow-up period. Each participant will be assessed every month during the treatment and three months after treatment as follow-up.

Conditions

Post COVID-19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

Individualized-Chinese herbal medicine

I. Lung and spleen qi deficiency syndrome Clinical manifestations: shortness of breath, fatigue, fatigue, anorexia, nausea, fullness, weak stool, and uneasiness. The tongue is pale and greasy. Recommended prescription: French Pinellia 9g, Chenpi 10g, Codonopsis 15g, Sunburn Astragalus 30g, Stir-fried Atractylodes 10g, Poria 15g, Huoxiang 10g, Amomum villosum 6g (later), and Licorice 6g

II. Qi and Yin deficiency syndrome Clinical manifestations: fatigue, shortness of breath, dry mouth, thirst, palpitations, sweating, poor appetite, low or no lever, dry cough and little sputum; dry tongue, fine or weak pulses. Recommended prescription: North and south radix salviae 10g, 15g ophiopogonis, 6g American ginseng, 6g schisandra, 6g gypsum l5g, 10g light bamboo leaves, 10g mulberry leaves, 15g reed root, 15g salviae miltiorrhiza, 6g raw liquorice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants under the COVID-19 Rehabilitation Program who have been previously diagnosed to be infected with COVID-19 and discharged from local hospitals after treatment with western medicine, with negative results from COVID-19 virus detection.

Exclusion Criteria

• Participants will be excluded if they have one or more of the followings: 1) inability to communicate (e.g. cognitive impairment); 2) history of CHM allergies; 3) incompetent in giving consent.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

ZhaoXiang Bian

Chair Professor/Director of Clinical Division, SCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi Bin FENG, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong

Ching LIONG, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, The Chinese University of Hong Kong

Locations

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaoxiang Bian, PhD

Role: CONTACT

bzxiang@hkbu.edu.hk

34112905

Facility Contacts

Linda Zhong, PhD

Role: primary

ldzhong@hkbu.edu.hk

852-34116523

Other Identifiers

HA Covid-19

Identifier Type: -

Identifier Source: org_study_id