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

Post COVID-19 Clinical Trial

Official title:

Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544605
• Other study ID #: HA Covid-19
• Status: Recruiting
• Start date: September 7, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: Hong Kong Baptist University
• Contact: Zhaoxiang Bian, PhD
• Phone: 34112905
• Email: bzxiang[@]hkbu.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Post COVID-19

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	School of Chinese Medicine, Hong Kong Baptist University	Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Chinese University of Hong Kong, The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Lung Function Questionnaire in Lung Function Assessment	Lung Function Questionnaire is a simple, brief, self-administered instrument to identify patients appropriate for lung function evaluation by 5 items about the breathing problems &/or frequent cough.; The questions are: How often do you cough up mucus?; How often does your chest sound noisy (wheezy, whistling, rattling) when you breathe?; How often do you experience shortness of breath during physical activity (walking up a flight of stairs or walking up an incline without stopping to rest)?; How many years have you smoked?; What is your age?; Scale: For Q1-Q3: 5=Never, 4=Rarely, 3=Sometimes, 2=Often, and 1=Very often For Q4: 5=Never, 4=?10yrs, 3=11-20yrs, 2=21-30yrs, 1=>30yrs For Q5: 5=<40yrs, 4=40-49yrs, 3=50-59yrs, 2=60-69yrs, 1=?70yrs; Score interpretation: Total Score of 18 or less suggests increased risk of Chronic Obstructive Pulmonary Disease.	9 months
Secondary	Blood Pressure in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participant's blood pressure (Systolic/Diastolic) in mmHg will be recorded before and after 6MWT on each visit.	9 months
Secondary	Pulse in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participant's pulse (beats per minute) will be recorded before and after 6MWT on each visit.	9 months
Secondary	SpO2 in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participant's SpO2 (%) will be recorded before and after 6MWT on each visit.	9 months
Secondary	Distance Walked in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participant's distance walked (m) will be recorded during 6MWT on each visit.	9 months
Secondary	Number of Rests in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participant's number of rests (number) will be recorded during 6MWT on each visit.	9 months
Secondary	MRC Dyspnoea Scale in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participants' lung function will be assessed using MRC Dyspnoea Scale during 6MWT on each visit, for grading the effect of breathlessness on daily activities. This scale measures perceived respiratory disability and allows the patients to indicate the extent to which their breathlessness affects their mobility.; The 1-5 grade scale is used alongside the questionnaire to establish the degree of breathlessness related to activity.	9 months
Secondary	Borg Scale of Perceived Exertion in 6-minute Walk Test (6MWT)	The six-minute walk test (6MWT) measures the distance the participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.; Participants' Borg Scale of Perceived Exertion ("Borg Score") will be recorded, by asking the participants to rate their exertion on the scale, taking into consideration feelings of physical stress and fatigue focusing on the whole feeling of exertion during 6MWT.; Scoring used in Borg RPE: 6=No exertion 7-8=Extremely light 9-10=Very light 11-12=Light 13-14=Somewhat hard 15-16=Hard 17-18=Very hard 19=Extremely hard 20=Maximal exertion	9 months
Secondary	Peak Expiratory Flow (PEF) in Spirometry Assessment	Peak Expiratory Flow (PEF) in litres per second (L/S) is recorded in Spirometry Assessment on each visit to determine participants' lung functionality.; Peak flow readings are higher when patients are well, and lower when the airways are constricted.	9 months
Secondary	Forced Expiratory Volume in 1 second (FEV1) in Spirometry Assessment	Forced expiratory volume in 1 second (FEV1) in Litres (L) is recorded in Spirometry Assessment on each visit to determine participants' lung functionality by assessing how much air the participants can force from their lungs in one second. Lower FEV-1 readings indicate more significant obstruction.	9 months
Secondary	Force Vital Capacity (FVC) in Spirometry Assessment	Force vital capacity (FVC) in Litres (L) is recorded in Spirometry Assessment on each visit to determine participants' lung functionality by assessing the largest amount of air that the participants can forcefully exhale after breathing in as deeply as they can. A lower than normal FVC reading indicates restricted breathing.	9 months
Secondary	FEV1/FVC ratio (%) in Spirometry Assessment	FEV1 and FVC recorded will be used to calculate the FEV1/FVC ratio (FEV1%) which is the ratio of FEV1 to FVC. In healthy adults this should be approximately 70-80% (declining with age). In obstructive diseases (asthma, COPD, chronic bronchitis, emphysema) FEV1 is diminished because of increased airway resistance to expiratory flow.; FEV1% of the participants are recorded during each visit, to assess any increased airway resistance to expiratory flow. In restrictive diseases (such as pulmonary fibrosis) the FEV1 and FVC are both reduced proportionally and the value may be normal or even increased as a result of decreased lung compliance.	9 months
Secondary	Quality of Life (WHO-QOL BREF HK)	The World Health Organization Quality of Life Brief Assessment [WHOQOL-BREF (HK)] (Leung, K F; Tay, M., Cheng, S. S. W., Lin, 1997) was validated in Hong Kong and widely use in academia and clinicians since 1997. This is a 5-point Likert scale with a total of 28 Questions to identify the perceived QOL of the participants. There are four domains namely Physical Health, Psychological, Social and Environment domains with a maximum of 100.	9 months
Secondary	Assessment on Western Medicine Visit Frequency	Frequency of clinic/hospital visits for western medicine during the treatment and follow up period	9 months