search
Back to results

RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Chinese Herb
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hong Kong Institute of Integrative MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment (Yinqiaosan-Maxingganshitang )

Placebo

Arm Description

Chinese Medicine granules

Placebo granules

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.
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.
Time of remission of cough
Time from the start of treatment to the symptom remission
Time of remission of fatigue
Time from the start of treatment to the symptom remission
Disappearance rate of COVID symptom
The disappearance rate of the COVID symptom
Incidence to severe illness
Incidence of the progression to severe ot critical illness during the trial
Mortality
All-cause mortality at the 21th days after stopping the medications
Utilization rate of rescue drugs
Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days
Dosage of rescue drugs
Dosage of antipyretic, Paxlovid and molnupiravir within 14 days

Full Information

First Posted
March 23, 2023
Last Updated
July 6, 2023
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT05787327
Brief Title
RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active treatment (Yinqiaosan-Maxingganshitang )
Arm Type
Experimental
Arm Description
Chinese Medicine granules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo granules
Intervention Type
Drug
Intervention Name(s)
Chinese Herb
Other Intervention Name(s)
CM
Intervention Description
Yinqiaosan-Maxingganshitang granules
Intervention Type
Diagnostic Test
Intervention Name(s)
Placebo
Other Intervention Name(s)
Plavebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time for the body temperature to change to normal
Description
The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours).
Time Frame
From baseline to week 19
Secondary Outcome Measure Information:
Title
Time of negative Rapid Antigen Test
Description
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)
Time Frame
From baseline to reaching outcome
Title
Remission rate of cough
Description
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.
Time Frame
14 days
Title
Remission rate of fatigue
Description
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.
Time Frame
14 days
Title
Time of remission of cough
Description
Time from the start of treatment to the symptom remission
Time Frame
From baseline to week 19
Title
Time of remission of fatigue
Description
Time from the start of treatment to the symptom remission
Time Frame
From baseline to week 19
Title
Disappearance rate of COVID symptom
Description
The disappearance rate of the COVID symptom
Time Frame
14 days
Title
Incidence to severe illness
Description
Incidence of the progression to severe ot critical illness during the trial
Time Frame
From baseline to 19 weeks
Title
Mortality
Description
All-cause mortality at the 21th days after stopping the medications
Time Frame
21 days
Title
Utilization rate of rescue drugs
Description
Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days
Time Frame
14 days
Title
Dosage of rescue drugs
Description
Dosage of antipyretic, Paxlovid and molnupiravir within 14 days
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cho Wing Lo
Phone
35053476
Email
louislo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiu Lin
Organizational Affiliation
Hong Kong Institute of Integrative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Institute of Integrative Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiu LIN
Phone
28733252

12. IPD Sharing Statement

Learn more about this trial

RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19

We'll reach out to this number within 24 hrs