COVID-19Phase 2NCT05787327
RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19
A Phase 2 study testing Chinese Herb in people with COVID-19, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Chinese Herb
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 May 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years;
- Tested positive for COVID-19 by RATs, Deep Throat Saliva (DTS) or Throat/Nasal swab RT-PCR tests;
- Patient diagnosed with mild to moderate COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health;
- Duration of symptoms ≤ 72 hours (Start from the presence of the major symptoms of COVID-19: Fever: oral temperature >37.2°C, or cough score ≥2, or fatigue score ≥2);
- Diagnosed with pattern of wind and heat invading the surface and/or pattern of intense exuberance of lung heat by a registered Chinese medicine practitioner (CMP) (Diagnostic criteria are the corresponding criteria in the "Diagnosis standards for common syndromes in traditional Chinese medicine)" published by "Diagnostic Subcommittee of China Association of Traditional Chinese Medicine in 2008, with ≥20 as the threshold for determination);
- Explicit declaration of willingness to participate in the study at the time of videoconference screening after reading the electronic informed consent form (written consent form have to signed after inclusion).
Who cannot join
- Diagnosed of Asymptomatic or Presymptomatic Infection, Severe Illness or Critical Illness of COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health
- Known allergy to the Chinese medicines or other ingredients of the investigational medicinal products (IMP) used in this study;
- Known pregnancy or lactation;
- Known immunocompromised patient (such as malignancy, organ or bone marrow transplant, AIDS or low immune function caused by long-term use of corticosteroids or other immunosuppressants)
- Known obesity (Body Mass Index [BMI] ≥30)
- Heavy smoker (≥400 cigarettes/year)
Show all 11Show fewer
- Known history of cardiovascular and cerebrovascular diseases (including hypertension), chronic lung disease (chronic obstructive pulmonary disease, moderate and severe asthma or interstitial lung disease), diabetes, chronic liver disease (ALT/AST ≥ 2× the upper limit of normal [ULN], Bilirubin-Total ≥ 1.5ULN), chronic kidney disease (Creatinine ≥1.5ULN), cancer or other chronic diseases.
- Known history of dysphagia or any gastrointestinal disorder that affects drug absorption (such as gastroesophageal reflux disease [GERD], chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, gastrectomy);
- Suspected or known history of alcohol or substance abuse or mental illness;
- Subjects having participated in other clinical studies in the past three months;
- Any other condition that in the opinion of the investigators could compromise the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Institute of Integrative Medicine
Hong Kong
Zhixiu LIN, 28733252
About this study
Official title: Assessing the Efficacy and Safety of Yinqiaosan-Maxingganshitang in the Treatment of the Major Symptoms of Mild and Moderate COVID-19 by Telemedicine - a Randomized, Double-blind, Placebo-controlled Trial
This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine.
Read the detailed description
Subjects who are diagnosed with COVID-19 by RATs or PCR tests and fulfilled the eligibility criteria will receive a maximum of 14 days of treatment with Yinqiaosan-Maxingganshitang (with or without specified additions) or placebo and will be followed up on day 7, 14 and 35 after receiving medication (day 0).
- Conditions
- COVID-19
- Being tested
- Chinese Herb, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese HerbDrug
Also called CM
Yinqiaosan-Maxingganshitang granules
PlaceboDiagnostic test
Also called Plavebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (Yinqiaosan-Maxingganshitang ) | Experimental | Chinese Medicine granules Receives: Drug: Chinese Herb |
| Placebo | Placebo comparator | Placebo granules Receives: Diagnostic Test: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for the body temperature to change to normal
The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours).
Measured: From baseline to week 19
Secondary outcomes (10)
Time of negative Rapid Antigen Test
- The negative rate of Rapid Antigen Tests (RATs) at day 14 and the negative conversion time (two successive negative RATs result with at least 24 hours interval)
Measured: From baseline to reaching outcome
Remission rate of cough
The remission of cough will be measured by the score rating from 0 to 4, which representing "None", "Mild", "Moderate", "Severe" and "Very severe" respectively.
The score of 1 or below and maintain for 24 hours will be counted as remission.
Measured: 14 days
Remission rate of fatigue
The remission of fatigue will be measured by the score rating from 0 to 4, which representing "None", "Mild", "Moderate", "Severe" and "Very severe" respectively.
The score of 1 or below and maintain for 24 hours will be counted as remission.
Measured: 14 days
Time of remission of cough
Time from the start of treatment to the symptom remission
Measured: From baseline to week 19
Time of remission of fatigue
Time from the start of treatment to the symptom remission
Measured: From baseline to week 19
Disappearance rate of COVID symptom
The disappearance rate of the COVID symptom
Measured: 14 days
Incidence to severe illness
Incidence of the progression to severe ot critical illness during the trial
Measured: From baseline to 19 weeks
Mortality
All-cause mortality at the 21th days after stopping the medications
Measured: 21 days
Utilization rate of rescue drugs
Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days
Measured: 14 days
Dosage of rescue drugs
Dosage of antipyretic, Paxlovid and molnupiravir within 14 days
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start25 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787327
- Sponsor's protocol ID
- COVID Acute study
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sum CH, Li TW, Zhang H, Hung HY, Fong BYF, Lin WL, Chow TY, Leung KC, Lo CW, Chia CP, Chan KL, Lin ZX. Assessing the efficacy and safety of Yinqiao powder-maxing Ganshi decoction in the treatment of the major symptoms of mild and moderate COVID-19 by telemedicine-study protocol for a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2024 Jan 8;14:1261338. doi: 10.3389/fphar.2023.1261338. eCollection 2023.
PubMed 38259270
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety of Yinqiaosan-Maxingganshitang in the Treatment of the Major Symptoms of Mild and Moderate COVID-19 by Telemedicine - a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05787327
- Acronym / sponsor ID
- COVID Acute study
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Mar 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 randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine.
Detailed description
Subjects who are diagnosed with COVID-19 by RATs or PCR tests and fulfilled the eligibility criteria will receive a maximum of 14 days of treatment with Yinqiaosan-Maxingganshitang (with or without specified additions) or placebo and will be followed up on day 7, 14 and 35 after receiving medication (day 0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment (Yinqiaosan-Maxingganshitang ) | Experimental | Drug: Chinese HerbChinese Medicine granules |
| Placebo | Placebo comparator | Diagnostic Test: PlaceboPlacebo granules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 65 years;
- Tested positive for COVID-19 by RATs, Deep Throat Saliva (DTS) or Throat/Nasal swab RT-PCR tests;
- Patient diagnosed with mild to moderate COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health;
- Duration of symptoms ≤ 72 hours (Start from the presence of the major symptoms of COVID-19: Fever: oral temperature >37.2°C, or cough score ≥2, or fatigue score ≥2);
- Diagnosed with pattern of wind and heat invading the surface and/or pattern of intense exuberance of lung heat by a registered Chinese medicine practitioner (CMP) (Diagnostic criteria are the corresponding criteria in the "Diagnosis standards for common syndromes in traditional Chinese medicine)" published by "Diagnostic Subcommittee of China Association of Traditional Chinese Medicine in 2008, with ≥20 as the threshold for determination);
Key exclusion criteria (11 listed)
- Diagnosed of Asymptomatic or Presymptomatic Infection, Severe Illness or Critical Illness of COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health
- Known allergy to the Chinese medicines or other ingredients of the investigational medicinal products (IMP) used in this study;
- Known pregnancy or lactation;
- Known immunocompromised patient (such as malignancy, organ or bone marrow transplant, AIDS or low immune function caused by long-term use of corticosteroids or other immunosuppressants)
- Known obesity (Body Mass Index [BMI] ≥30)
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 |
|---|---|---|
| Chinese HerbAlso: CMYinqiaosan-Maxingganshitang granules | Drug | Active treatment (Yinqiaosan-Maxingganshitang ) |
| PlaceboAlso: PlaveboPlacebo | Diagnostic test | Placebo |
Primary outcome
Time for the body temperature to change to normal
Time frame: From baseline to week 19
The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours).
10 secondary outcomes
Time of negative Rapid Antigen Test
Time frame: From baseline to reaching outcome
Remission rate of cough
Time frame: 14 days
Remission rate of fatigue
Time frame: 14 days
Time of remission of cough
Time frame: From baseline to week 19
Time of remission of fatigue
Time frame: From baseline to week 19
Disappearance rate of COVID symptom
Time frame: 14 days
Incidence to severe illness
Time frame: From baseline to 19 weeks
Mortality
Time frame: 21 days
Utilization rate of rescue drugs
Time frame: 14 days
Dosage of rescue drugs
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Derived from this study: PubMed 38259270Sum CH, Li TW, Zhang H, Hung HY, Fong BYF, Lin WL, Chow TY, Leung KC, Lo CW, Chia CP, Chan KL, Lin ZX. Assessing the efficacy and safety of Yinqiao powder-maxing Ganshi decoction in the treatment of the major symptoms of mild and moderate COVID-19 by telemedicine-study protocol for a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2024 Jan 8;14:1261338. doi: 10.3389/fphar.2023.1261338. eCollection 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.
Zhixiu Lin principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese Herb in people with COVID-19, run by Chinese University of Hong Kong at 1 site in 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cho Wing Lo (35053476, louislo@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for the body temperature to change to normal (time frame: From baseline to week 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05787327, which also lists 1 linked publication.
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 30 Jul 2026.