Chinese Medicine for Patients With LCOVID-19 Symptoms
Chinese Medicine for Residue Symptoms of COVID-19 Recovered Patients- A Double-blind, Randomized, Placebo-controlled Study
1 other identifier
interventional
68
1 country
1
Brief Summary
COVID-19 has spread rapidly and now affects all over the world. On 11 March 2020, coronavirus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organization (WHO). Most of the infected people will develop mild to moderate illness, for example fever, cough, tiredness and joint pain etc. For some older people, and those with comorbidities like cardiovascular disease, diabetes, chronic respiratory disease, and malignancy are more likely to develop serious illness. Also long-term problems such as fatigue, breathlessness and joint pain experienced by survivors of COVID-19 after discharge from hospital. Some clinical and pharmacological studies have suggested Traditional Chinese Medicine (TCM) has achieved remarkable therapeutic effect for active COVID cases of different severity during SARS epidemic in 2003. Also, some studies shown that using Chinese medicine interventions together with conventional treatment is more effective than using the conventional treatment alone in treating chronic fatigue syndrome. Traditional Chinese Medicine (TCM) has a long history and played an important role in the prevention and treatment of several epidemic diseases. However, there is a lack of clinical study of using TCM to treat the residue symptom of COVID-19 recovered patients. COVID-19 recovered patients will be screened and randomized into TCM group or placebo group for 8 weeks and followed by a post-treatment visits at week 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Jan 2022
Longer than P75 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 14, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJanuary 28, 2022
January 1, 2022
1.1 years
June 10, 2021
January 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Change of Fatigue Severity Score
Improvement of residue COVID-19 symptoms of fatigue after study treatment at week 8, using a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9 - 63; the higher the score, the greater fatigue severity.
8 weeks
Secondary Outcomes (6)
Long Term Symptom Assessment
8 weeks
The Change of Fatigue Severity Score (FSS)
12 weeks
Improvement of dyspnoea using modified British Medical Research Council (mMRC) dyspnoea scale
8 weeks and 12weeks
The change of EuroQol five-dimension five-level (EQ-5D-5L)5L) questionnaire and it's Visual Analogue Scale (VAS)
8 weeks and 12weeks
Pulmonary function assessment on FEV1, FVC, and FEV1/FVC ratio
8 weeks
- +1 more secondary outcomes
Study Arms (2)
Active Arm
EXPERIMENTALCOVID Rehab Formula granules once daily for 8 weeks
Placebo Arm
PLACEBO COMPARATORPlacebo granules once daily for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Aged above 18;
- Have fatigue and one more residue symptoms (e.g. dyspnoea, sleep disturbance, cough, loose stool, abdominal distension, loss of appetite, dizziness, etc.) at least 5 weeks after discharge
- Patients are diagnosed with "lung-spleen qi deficiency"(肺脾氣虛) and/or"dual deficiency of qi and yin"(氣陰兩虛) by a Chinese Medicine Practitioner
- Voluntary written consent.
You may not qualify if:
- Still being SARS-CoV-2 positive
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
- Impaired hematological profile and liver / renal function;
- No concomitant non-steroidal anti-inflammatory drugs (NSAIDs), steroids, antibiotics, prebiotics, probiotics within 4 weeks;
- Known allergic history to any Chinese herbal medicines;
- Known pregnancy or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Chinese University of Hong Kong
Shatin, Hong Kong
Related Publications (1)
Sum CH, Ching JYL, Song T, Cheong PK, Lo CW, Lai MK, Chia CP, Chan KL, Mak WY, Leung KC, Leung SB, Zhang H, Lin Z. Chinese medicine for residual symptoms of COVID-19 recovered patients (long COVID)-A double-blind, randomized, and placebo-controlled clinical trial protocol. Front Med (Lausanne). 2023 Jan 4;9:990639. doi: 10.3389/fmed.2022.990639. eCollection 2022.
PMID: 36687403DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhixiu Lin, PhD
Hong Kong Institute of Integrative Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 14, 2021
Study Start
January 1, 2022
Primary Completion
January 31, 2023
Study Completion
June 30, 2023
Last Updated
January 28, 2022
Record last verified: 2022-01