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CompletedNCT04924881Updated Jul 27, 2026

Chinese Medicine for Patients With LCOVID-19 Symptoms

A Phase 2 interventional study of COVID Rehab Formula granules and Placebo granules in Covid19, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases. A novel coronavirus (nCoV) is a new strain that has not been previously identified in humans. COVID-19 has spread rapidly and now affects all over the world. As of 31 Jan 2021, over 100 million COVID-19 confirmed cases were reported worldwide, with more than 2 million related death.

Up to now, most frequently used therapies are corticosteroids, antiviral agents, antiviral/immunomodulatory drugs, serotherapy, anticoagulant and inflammation inhibitors. Recent studies reported that different kinds of residue symptoms were left after patient discharged from the hospital, such as fatigue, breathlessness and joint pain.

During SARS epidemic in 2003, the treatment of Traditional Chinese Medicine (TCM) has achieved remarkable therapeutic effect. Many different types of TCM have been proposed to treat COVID-19, of which the most famous are "three medicines and three formulae": Jinhua Qinggan Granule, Lianhua Qingwen Capsule/Granule, Xuebijing Injection; Lung Cleansing and Detoxifying Decoction, HuaShiBaiDu Formula and XuanFeiBaiDu Formula, which are mainly used for active COVID cases of different severity. Clinical and pharmacological studies have suggested their efficacy, safety and possible mechanisms in treating different stages of COVID-19, either used along with conventional treatment or independently.

For residual symptoms seen in COVID recovered patients, such as fatigue, dyspnoeaand insomnia, there are also studies suggesting that TCM may be helpful. 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.

Liujunzhi Decoction (LJZD) and Shashen Maidong Decoction (SSMDD) are classic Chinese medicine formulae that have been used in China for hundreds of years. Their combination is proposed as the intervention of this trial because, from the perspective of Chinese medicine, the residual symptoms of COVID-19 can often be seen as the manifestation of "lung-spleen qi deficiency" or "qi and yin deficiency". ModifiedLJZD and SSMDD are the two most frequently recommended formulae versions in the recovery stage of COVID-19. This study is to evaluate the efficacy of using COVID Rehab Formula "CRF"(LJZD and SSMDD with variations) on the residue symptom of COVID-19 recovered subjects. To evaluate the efficacy of using COVID Rehab Formula "CRF" on the residue symptom of COVID-19 recovered subjects. COVID-19 recovered patients will be randomly assigned to TCM group or placebo group for study treatment 8 weeks and followed by a post-treatment visits at week 12.

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 68 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Active Arm

    COVID Rehab Formula granules once daily for 8 weeks

    Drug: COVID Rehab Formula granules

  • Placebo comparator
    Placebo Arm

    Placebo granules once daily for 8 weeks

    Other: Placebo granules

Interventions

  • DrugCOVID Rehab Formula granules

    COVID Rehab Formula granules once daily for 8 weeks

  • OtherPlacebo granules

    Placebo granules once daily for 8 weeks

06

What researchers measure

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.

    Time frame: 8 weeks

Secondary outcomes

  1. Long Term Symptom Assessment

    Self-reported long term COVID-19 symptoms For the symptom questionnaire, participants will be asked to report newly occurring and persistent symptoms, or any symptoms worse than before COVID 19 development. The symptom assessment has 5 scale, from none to very severe.

    Time frame: 8 weeks

  2. The Change of Fatigue Severity Score (FSS)

    FSS is 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.

    Time frame: 12 weeks

  3. Improvement of dyspnoea using modified British Medical Research Council (mMRC) dyspnoea scale

    The mMRC scale is a five-category scale to characterize the level of dyspnoea with physical activity in which higher scores correspond with increased dyspnoea.

    Time frame: 8 weeks and 12weeks

  4. The change of EuroQol five-dimension five-level (EQ-5D-5L)5L) questionnaire and it's Visual Analogue Scale (VAS)

    To evaluate patients quality of life (QoL) by using EQ-5D-5L, higher score better QoL. EuroQol Visual Analogue Scale assess generic health ranging from 0-100, higher score better health experience.

    Time frame: 8 weeks and 12weeks

  5. Pulmonary function assessment on FEV1, FVC, and FEV1/FVC ratio

    FEV1, FVC, and FEV1/FVC ratio will be measured with the Air Next Spirometer (NuvoAir, Sweden) in combination with the mobile coaching system. The higher of FEV1/FVC ratio, the healthier of subjects.

    Time frame: 8 weeks

  6. Adverse event assessment

    Any reported adverse event related to study treatment will be analyzed throughout the study.

    Time frame: 8 weeks and 12weeks

07

Study locations

1 site
  • The Chinese University of Hong Kong
    Shatin, Hong Kong
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References and documents

Publications

  • 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. PubMed 36687403 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04924881
Lead sponsor
Chinese University of Hong Kong
Responsible party
Prof. Lin Zhixiu (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jun 14, 2021
Start date
Jul 2, 2021
Primary completion
Oct 3, 2022
Completion
Oct 3, 2022
Last update
Jul 27, 2026

Study contacts

Zhixiu Lin, PhD
principal investigator · Hong Kong Institute of Integrative Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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