Post COVID-19NCT04544605
Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients
An observational study of Post COVID-19, run by Hong Kong Baptist University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post COVID-19
- What is being tested?
- Individualized-Chinese herbal medicine
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at CMCTRs, previously diagnosed to be infected with COVID-19 and discharged from Hong Kong local hospitals.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Chinese Medicine, Hong Kong Baptist University
Hong Kong, Hong Kong
Linda Zhong, PhD, 852-34116523, ldzhong@hkbu.edu.hk
About this study
Official title: Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients: An Observational Study
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.
Read the 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:
- 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.
- 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
- Being tested
- Individualized-Chinese herbal medicine
- Keywords
- COVID-19, Special Chinese Medicine Out-patient Programme, Discharged COVID-19 Patients Observational Study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized-Chinese herbal medicineOther
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline the Body Constitution at 9 months
Secondary outcomes (14)
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
Assessment on Western Medicine Visit Frequency
Frequency of clinic/hospital visits for western medicine during the treatment and follow up period
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start7 Sep 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Yi Bin FENG, PhD, Principal investigator, School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong KongChing LIONG, PhD, Principal investigator, School of Chinese Medicine, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544605
- Sponsor's protocol ID
- HA Covid-19
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients: An Observational Study
- ClinicalTrials.gov ID
- NCT04544605
- Acronym / sponsor ID
- HA Covid-19
- Conditions
- Post COVID-19
- Keywords
- COVID-19, Special Chinese Medicine Out-patient Programme, Discharged COVID-19 Patients Observational Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at CMCTRs, previously diagnosed to be infected with COVID-19 and discharged from Hong Kong local hospitals.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized-Chinese herbal medicineI. 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. | Other | – |
Primary outcome
Change in CM Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
Time frame: Change from Baseline the CM Diagnostic Pattern & Clinical Characteristics at 9 months
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 in Body Constitution Scores using Body Constitution Questionnaires Assessment
Time frame: Change from Baseline the Body Constitution at 9 months
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.
14 secondary outcomes
Lung Function Questionnaire in Lung Function Assessment
Time frame: 9 months
Blood Pressure in 6-minute Walk Test (6MWT)
Time frame: 9 months
Pulse in 6-minute Walk Test (6MWT)
Time frame: 9 months
SpO2 in 6-minute Walk Test (6MWT)
Time frame: 9 months
Distance Walked in 6-minute Walk Test (6MWT)
Time frame: 9 months
Number of Rests in 6-minute Walk Test (6MWT)
Time frame: 9 months
MRC Dyspnoea Scale in 6-minute Walk Test (6MWT)
Time frame: 9 months
Borg Scale of Perceived Exertion in 6-minute Walk Test (6MWT)
Time frame: 9 months
Peak Expiratory Flow (PEF) in Spirometry Assessment
Time frame: 9 months
Forced Expiratory Volume in 1 second (FEV1) in Spirometry Assessment
Time frame: 9 months
Force Vital Capacity (FVC) in Spirometry Assessment
Time frame: 9 months
FEV1/FVC ratio (%) in Spirometry Assessment
Time frame: 9 months
Quality of Life (WHO-QOL BREF HK)
Time frame: 9 months
Assessment on Western Medicine Visit Frequency
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Bin FENG, PhD principal investigator
School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong
Ching LIONG, PhD principal investigator
School of Chinese Medicine, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post COVID-19, run by Hong Kong Baptist University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoxiang Bian, PhD (34112905, bzxiang@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CM Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment (time frame: Change from Baseline the CM Diagnostic Pattern & Clinical Characteristics at 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.