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

NCT04544605 | Unknown DMC

• 1 other identifier: HA Covid-19
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Post COVID-19

Keywords

COVID-19; Special Chinese Medicine Out-patient Programme; Discharged COVID-19 Patients Observational Study

Outcome Measures

Primary Outcomes (2)

• Change in CM Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment

  The changes in participants' health as characterized by CM diagnostic pattern \& clinical characteristics using CM Syndrome Differentiation according to the Guidelines for Chinese Medicine New Drug Clinical Study (China Medical Science Press, 2002) will be assessed on each visit during the treatment and follow up period.

  Change from Baseline the CM Diagnostic Pattern & Clinical Characteristics at 9 months

• Change in Body Constitution Scores using Body Constitution Questionnaires Assessment

  The changes in participants' health as characterized by body constitution scores using the Body Constitution Questionnaires for the nine specific types of body constitutions will be assessed on each visit during the treatment and follow up period.

  Change from Baseline the Body Constitution at 9 months

Secondary Outcomes (14)

• Lung Function Questionnaire in Lung Function Assessment

  9 months

• Blood Pressure in 6-minute Walk Test (6MWT)

  9 months

• Pulse in 6-minute Walk Test (6MWT)

  9 months

• SpO2 in 6-minute Walk Test (6MWT)

  9 months

• Distance Walked in 6-minute Walk Test (6MWT)

  9 months

Interventions

Individualized-Chinese herbal medicine OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at CMCTRs, previously diagnosed to be infected with COVID-19 and discharged from Hong Kong local hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• The University of Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

RECRUITING

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

• Yi Bin FENG, PhD

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

  PRINCIPAL INVESTIGATOR

• Ching LIONG, PhD

  School of Chinese Medicine, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoxiang Bian, PhD

CONTACT

34112905; bzxiang@hkbu.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor/Director of Clinical Division, SCM

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: September 7, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

CN (1)