Long COVIDPhase 2NCT06095258
A Practical RCT of TCM in the Treatment of LCOVID and Analysis of Syndrome Types and Medication Characteristics.
A Phase 2 study testing Traditional Chinese medicine treatment and Western medicine treatment in people with Long COVID, run by Chinese University of Hong Kong.
Trial summary
This is a multi-center, outcome assessor-blinded, practical randomized controlled trial, aiming to compare the actual clinical effectiveness of individualized traditional Chinese medicine and conventional Western medicine in the treatment of long COVID. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Traditional Chinese medicine treatment and Western medicine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 28 Feb 2026
- Phase
- Phase 2
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chinese subjects with age between 6 and 80 years old;
- For those who have recovered from COVID-19, it has been more than 28 days since the date of diagnosis (the diagnosis is confirmed by rapid antigen test or positive nucleic acid test of deep throat saliva or nose/throat swab);
- The average score of the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) is above 2 (i.e. above the moderate level).
Who cannot join
- People who have not been infected with COVID-19;
- People who are still positive for COVID-19;
- Known history of some certain serious medical disease, which is in an unstable state or even affects basic survival, such as cardiovascular disease, liver or renal dysfunction, diabetes, cancer, cerebrovascular disease, blood disorders;
- Known impaired hematological characteristics or impaired liver/kidney function;
- People with mild cognitive impairment, that is, those whose age/education matching percentile in the score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) is lower than 16; or those who cannot truthfully fill out the questionnaire due to mental and psychological factors;
- Have used any drugs or other treatment methods for the treatment of COVID-19 in the past week, such as acupuncture, massage, scraping, cupping, etc.;
- Known history of allergy to any traditional Chinese medicine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Practical Clinical Randomized Controlled Trial of Traditional Chinese Medicine in the Treatment of Long COVID and an Analysis of Syndrome Types and Medication Characteristics of Traditional Chinese Medicine
This is a multi-center, outcome assessor-blinded, practical randomized controlled trial, aiming to compare the actual clinical effectiveness of individualized traditional Chinese medicine and conventional Western medicine in the treatment of long COVID.
Totally 162 patients with long COVID recruited into the study will be randomly assigned to the traditional Chinese medicine treatment group or the Western medicine control group. Patients in the treatment group will receive individualized TCM syndrome differentiation treatment, and patients in the control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners for 4 weeks. All patients were followed up once a week (±2 days) during treatment period and followed up by 4 weeks (±2 days) after the treatment. Outcome measurements will be conducted at baseline, the end of treatment (week 4 ±2 days) and the follow-up visit (week 8 ±2 days).
Read the detailed description
The novel coronavirus has caused a global pandemic since the end of 2019. As of November 27, 2022, 637 million people have been diagnosed worldwide and more than 6 million people have died. Studies have reported that about 10%-20% of people will continue to have some post-infection symptoms after being infected with the new coronavirus. The World Health Organization (WHO) named it the Post COVID-19 Condition or Long COVID. The main symptoms of Long COVID include severe fatigue, shortness of breath, heart damage (such as myocarditis), cognitive impairment, sleep disturbance, post-traumatic stress disorder syndrome, muscle pain, decreased concentration, headache, impaired taste, and smell, etc.
In the face of the ongoing epidemic and more and more people being infected, people are increasingly concerned about the long-term impact of the new coronavirus infection. At present, western medicine is trying to adopt symptomatic treatment for some main symptoms of COVID-19. In addition, people are also trying many non-drug treatments, such as exercise, pulmonary rehabilitation training, cognitive behavioral therapy, etc.
Traditional Chinese medicine (TCM) has been strongly involved in the treatment and prevention of COVID-19 and the recovery of COVID-19 infection in the early stages of the epidemic. In order to cope with the fifth wave of the epidemic in Hong Kong, in April 2022, the Chinese government's Anti-epidemic Chinese Medicine Expert Group in Hong Kong launched the "Guidelines on the Rehabilitation of Traditional Chinese Medicine during the Recovery Period of Coronavirus Disease 2019 (Trial Version)". However, there is a lack of clinical research evidence that has practical guiding value for the TCM syndrome diagnosis and medication in long COVID patients. Secondly, there is a lack of reliable research evidence on the clinical effectiveness of individualized Chinese medicine treatment of long COVID. Thirdly, there is a lack of large-scale research data on patients with long COVID from clinical treatment. Fourthly, there is a lack of comparative research evidence between traditional Chinese medicine and conventional Western medicine.
Therefore, this study will be conducted in order to understand the possible advantages or disadvantages of traditional Chinese medicine compared with Western medicine; improve the efficacy of traditional Chinese medicine in the treatment of long COVID; and promote the application of traditional Chinese medicine in the field of long COVID treatment.
- Conditions
- Long COVID
- Being tested
- Traditional Chinese medicine treatment, Western medicine treatment
- Keywords
- Traditional Chinese medicine
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine treatmentDrug
Also called CM group
About four to six Chinese medicine practitioners with five to twenty years of clinical work experience will be responsible for patient diagnosis and prescription treatment, and use a uniformly designed data collection form to record the patient's medical history, clinical symptoms and signs, tongue and pulse conditions, and other information. Patients in the treatment group will receive individualized Chinese medicine treatment prescriptions. Patients in the control group received conventional Western medicine treatment, and about 3 to four Western medicine practitioners with five to twenty years of work experience will be responsible for the conventional medicine prescription. The treatment of the two groups will last for four weeks, and the patients will be followed up for four weeks after the treatment. A patient diary will be provided to all participants for recording the drug compliance and any adverse event during the treatment period.
Western medicine treatmentDrug
Also called WM group
Western medicine doctors will mainly use symptomatic drugs to treat long COVID. For example, cough medicine (such as codeine), bronchodilators (such as ventolin), expectorants (such as fluimucil) and so on are used to treat cough, shortness of breath, or other respiratory symptoms. Non-steroidal anti-inflammatory painkillers (such as panadol) are often used for treating headaches, and sedative-hypnotic drugs (such as stilnox) are often used to treat insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese medicine treatment group | Experimental | Patients in this treatment group will receive individualized TCM syndrome differentiation treatment. Receives: Drug: Traditional Chinese medicine treatment |
| Western medicine control group | Active comparator | Patients in this control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners. Receives: Drug: Western medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-level EQ-5D version (EQ-5D-5L)
The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated [38]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).
Measured: 4 weeks
5-level EQ-5D version (EQ-5D-5L)
The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated [38]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).
Measured: 8 weeks
Secondary outcomes (7)
Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)
The Chinese version of the Measure Yourself Medical Outcome Profile has been validated [39]. This questionnaire asks respondents to name one or two symptoms of greatest concern and the daily activities that are limited by these symptoms. Respondents rate these symptoms and activities, as well as their general health status, on a scale from 0 to 6 (0 is best, 6 is worst).
Measured: 4 weeks
Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)
The Chinese version of the Measure Yourself Medical Outcome Profile has been validated [39]. This questionnaire asks respondents to name one or two symptoms of greatest concern and the daily activities that are limited by these symptoms. Respondents rate these symptoms and activities, as well as their general health status, on a scale from 0 to 6 (0 is best, 6 is worst).
Measured: 8 weeks
Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
This improved version of the scale allows patients to self-assess the main symptoms of the COVID, the degree of functional limitation and overall health status. There are 17 items in total, including shortness of breath, cough/throat sensitivity/voice change, fatigue, changes in smell or taste, pain or discomfort, and cognition. problems, palpitations/dizziness, tiredness/exacerbation after work, anxiety/depression, sleep problems, communication, walking or moving, self-care, other daily activities, social roles), and other symptoms (such as fever, hair loss, dry eyes, tinnitus, nausea, etc.) and general health, etc. Each item is scored from 0 to 3 (0 is asymptomatic, 1 is mild and does not affect daily life, 2 is moderate and affects daily life to a certain extent, and 3 is severe or affects daily life comprehensively).
Measured: 4 weeks
Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
This improved version of the scale allows patients to self-assess the main symptoms of the COVID, the degree of functional limitation and overall health status. There are 17 items in total, including shortness of breath, cough/throat sensitivity/voice change, fatigue, changes in smell or taste, pain or discomfort, and cognition. problems, palpitations/dizziness, tiredness/exacerbation after work, anxiety/depression, sleep problems, communication, walking or moving, self-care, other daily activities, social roles), and other symptoms (such as fever, hair loss, dry eyes, tinnitus, nausea, etc.) and general health, etc. Each item is scored from 0 to 3 (0 is asymptomatic, 1 is mild and does not affect daily life, 2 is moderate and affects daily life to a certain extent, and 3 is severe or affects daily life comprehensively).
Measured: 8 weeks
Serum level change of inflammatory factors
Inflammatory markers including interferon (IFN-β), interferon (IFN-λ2/3), pentraxin 3 (PTX3) and interleukin 6 will be measured.
Measured: 4 weeks
Safety assessment
In order to evaluate the safety of the traditional Chinese medicine treatment, the patient's complete blood count (CBC) and liver and kidney function indicators will be tested before starting the study treatment and after the treatment ends.
Measured: 4 weeks
Adverse event
Subjects will be asked about the occurrence of any adverse events during the intervention period.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Totally 162 patients with long COVID recruited into the study will be randomly assigned to the traditional Chinese medicine treatment group or the Western medicine control group. Patients in the treatment group will receive individualized TCM syndrome differentiation treatment, and patients in the control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Hongwei, Chinese University of Hong Kong
- Investigators
- Hongwei Zhang, PhD, Principal investigator, School of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095258
- Sponsor's protocol ID
- Parametric LCOVID
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Practical Clinical Randomized Controlled Trial of Traditional Chinese Medicine in the Treatment of Long COVID and an Analysis of Syndrome Types and Medication Characteristics of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT06095258
- Acronym / sponsor ID
- Parametric LCOVID
- Conditions
- Long COVID
- Keywords
- Traditional Chinese medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
This is a multi-center, outcome assessor-blinded, practical randomized controlled trial, aiming to compare the actual clinical effectiveness of individualized traditional Chinese medicine and conventional Western medicine in the treatment of long COVID.
Totally 162 patients with long COVID recruited into the study will be randomly assigned to the traditional Chinese medicine treatment group or the Western medicine control group. Patients in the treatment group will receive individualized TCM syndrome differentiation treatment, and patients in the control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners for 4 weeks. All patients were followed up once a week (±2 days) during treatment period and followed up by 4 weeks (±2 days) after the treatment. Outcome measurements will be conducted at baseline, the end of treatment (week 4 ±2 days) and the follow-up visit (week 8 ±2 days).
Detailed description
The novel coronavirus has caused a global pandemic since the end of 2019. As of November 27, 2022, 637 million people have been diagnosed worldwide and more than 6 million people have died. Studies have reported that about 10%-20% of people will continue to have some post-infection symptoms after being infected with the new coronavirus. The World Health Organization (WHO) named it the Post COVID-19 Condition or Long COVID. The main symptoms of Long COVID include severe fatigue, shortness of breath, heart damage (such as myocarditis), cognitive impairment, sleep disturbance, post-traumatic stress disorder syndrome, muscle pain, decreased concentration, headache, impaired taste, and smell, etc.
In the face of the ongoing epidemic and more and more people being infected, people are increasingly concerned about the long-term impact of the new coronavirus infection. At present, western medicine is trying to adopt symptomatic treatment for some main symptoms of COVID-19. In addition, people are also trying many non-drug treatments, such as exercise, pulmonary rehabilitation training, cognitive behavioral therapy, etc.
Traditional Chinese medicine (TCM) has been strongly involved in the treatment and prevention of COVID-19 and the recovery of COVID-19 infection in the early stages of the epidemic. In order to cope with the fifth wave of the epidemic in Hong Kong, in April 2022, the Chinese government's Anti-epidemic Chinese Medicine Expert Group in Hong Kong launched the "Guidelines on the Rehabilitation of Traditional Chinese Medicine during the Recovery Period of Coronavirus Disease 2019 (Trial Version)". However, there is a lack of clinical research evidence that has practical guiding value for the TCM syndrome diagnosis and medication in long COVID patients. Secondly, there is a lack of reliable research evidence on the clinical effectiveness of individualized Chinese medicine treatment of long COVID. Thirdly, there is a lack of large-scale research data on patients with long COVID from clinical treatment. Fourthly, there is a lack of comparative research evidence between traditional Chinese medicine and conventional Western medicine.
Therefore, this study will be conducted in order to understand the possible advantages or disadvantages of traditional Chinese medicine compared with Western medicine; improve the efficacy of traditional Chinese medicine in the treatment of long COVID; and promote the application of traditional Chinese medicine in the field of long COVID treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Totally 162 patients with long COVID recruited into the study will be randomly assigned to the traditional Chinese medicine treatment group or the Western medicine control group. Patients in the treatment group will receive individualized TCM syndrome differentiation treatment, and patients in the control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners.
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese medicine treatment group | Experimental | Drug: Traditional Chinese medicine treatmentPatients in this treatment group will receive individualized TCM syndrome differentiation treatment. |
| Western medicine control group | Active comparator | Drug: Western medicine treatmentPatients in this control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese subjects with age between 6 and 80 years old;
- For those who have recovered from COVID-19, it has been more than 28 days since the date of diagnosis (the diagnosis is confirmed by rapid antigen test or positive nucleic acid test of deep throat saliva or nose/throat swab);
- The average score of the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) is above 2 (i.e. above the moderate level).
Key exclusion criteria (7 listed)
- People who have not been infected with COVID-19;
- People who are still positive for COVID-19;
- Known history of some certain serious medical disease, which is in an unstable state or even affects basic survival, such as cardiovascular disease, liver or renal dysfunction, diabetes, cancer, cerebrovascular disease, blood disorders;
- Known impaired hematological characteristics or impaired liver/kidney function;
- People with mild cognitive impairment, that is, those whose age/education matching percentile in the score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) is lower than 16; or those who cannot truthfully fill out the questionnaire due to mental and psychological factors;
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 |
|---|---|---|
| Traditional Chinese medicine treatmentAlso: CM groupAbout four to six Chinese medicine practitioners with five to twenty years of clinical work experience will be responsible for patient diagnosis and prescription treatment, and use a uniformly designed data collection form to record the patient's medical history, clinical symptoms and signs, tongue and pulse conditions, and other information. Patients in the treatment group will receive individualized Chinese medicine treatment prescriptions. Patients in the control group received conventional Western medicine treatment, and about 3 to four Western medicine practitioners with five to twenty years of work experience will be responsible for the conventional medicine prescription. The treatment of the two groups will last for four weeks, and the patients will be followed up for four weeks after the treatment. A patient diary will be provided to all participants for recording the drug compliance and any adverse event during the treatment period. | Drug | Traditional Chinese medicine treatment group |
| Western medicine treatmentAlso: WM groupWestern medicine doctors will mainly use symptomatic drugs to treat long COVID. For example, cough medicine (such as codeine), bronchodilators (such as ventolin), expectorants (such as fluimucil) and so on are used to treat cough, shortness of breath, or other respiratory symptoms. Non-steroidal anti-inflammatory painkillers (such as panadol) are often used for treating headaches, and sedative-hypnotic drugs (such as stilnox) are often used to treat insomnia. | Drug | Western medicine control group |
Primary outcome
5-level EQ-5D version (EQ-5D-5L)
Time frame: 4 weeks
The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated [38]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).
5-level EQ-5D version (EQ-5D-5L)
Time frame: 8 weeks
The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated [38]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).
7 secondary outcomes
Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)
Time frame: 4 weeks
Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)
Time frame: 8 weeks
Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Time frame: 4 weeks
Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Time frame: 8 weeks
Serum level change of inflammatory factors
Time frame: 4 weeks
Safety assessment
Time frame: 4 weeks
Adverse event
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
Hongwei Zhang, PhD principal investigator
School of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional Chinese medicine treatment and Western medicine treatment in people with Long COVID, run by Chinese University of Hong Kong.
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 3 inclusion and 7 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hongwei Zhang, PhD (39439845, zhanghw@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-level EQ-5D version (EQ-5D-5L) (time frame: 4 weeks). 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 26 Oct 2023.