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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment (Yinqiaosan-Maxingganshitang ) | Experimental | Chinese Medicine granules |
|
| Placebo | Placebo Comparator | Placebo granules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese Herb | Drug | Yinqiaosan-Maxingganshitang granules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to week 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of negative Rapid Antigen Test | 2. 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) | From baseline to reaching outcome |
| Remission rate of cough |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cho Wing Lo | Contact | 35053476 | louislo@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Zhixiu Lin | Hong Kong Institute of Integrative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Institute of Integrative Medicine | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38259270 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C099950 | Ephedrae herba |
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| Placebo | Diagnostic Test | Placebo |
|
|
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. |
| 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. | 14 days |
| Time of remission of cough | Time from the start of treatment to the symptom remission | From baseline to week 19 |
| Time of remission of fatigue | Time from the start of treatment to the symptom remission | From baseline to week 19 |
| Disappearance rate of COVID symptom | The disappearance rate of the COVID symptom | 14 days |
| Incidence to severe illness | Incidence of the progression to severe ot critical illness during the trial | From baseline to 19 weeks |
| Mortality | All-cause mortality at the 21th days after stopping the medications | 21 days |
| Utilization rate of rescue drugs | Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days | 14 days |
| Dosage of rescue drugs | Dosage of antipyretic, Paxlovid and molnupiravir within 14 days | 14 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |