This is a multi-center, outcome assessor-blinded, practical randomized controlled trial,aiming to compare the actual clinical effectiveness of individualized traditional Chinesemedicine and conventional Western medicine in the treatment of long COVID.Totally 162 patients with long COVID recruited into the study will be randomly assignedto the traditional Chinese medicine treatment group or the Western medicine controlgroup. Patients in the treatment group will receive individualized TCM syndromedifferentiation treatment, and patients in the control group will receive conventionalWestern medicine symptomatic treatment from general Western medicine practitioners for 4weeks. All patients were followed up once a week (±2 days) during treatment period andfollowed up by 4 weeks (±2 days) after the treatment. Outcome measurements will beconducted at baseline, the end of treatment (week 4 ±2 days) and the follow-up visit(week 8 ±2 days).
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.
Drug: Traditional Chinese medicine treatment
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.
Other Name: CM group
Drug: Western medicine treatment
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.
Other Name: WM group
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Not Provided
Hongwei Zhang, PhD
39439845
zhanghw@cuhk.edu.hk
Cho Wing Lo
35053476
louislo@cuhk.edu.hk
Hongwei Zhang, PhD, Principal Investigator
School of Chinese Medicine