Recruiting NCT05787327
RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chinese Herb, Placebo.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug Chinese Herb
Yinqiaosan-Maxingganshitang granules - Diagnostic test Placebo
Placebo
Primary outcome measures
- Time for the body temperature to change to normal [Time frame: From baseline to week 19]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Hong Kong Institute of Integrative Medicine — Hong Kong
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 PMID 38259270
Identifiers
NCT: NCT05787327 · COVID Acute study