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

NCT05787327 | Unknown Phase 2 DMC

• 1 other identifier: COVID Acute study
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Time of negative Rapid Antigen Test

  From baseline to reaching outcome

• Remission rate of cough

  14 days

• Remission rate of fatigue

  14 days

• Time of remission of cough

  From baseline to week 19

• Time of remission of fatigue

  From baseline to week 19

Study Arms (2)

Active treatment (Yinqiaosan-Maxingganshitang )

EXPERIMENTAL

Chinese Medicine granules

Drug: Chinese Herb

Placebo

PLACEBO COMPARATOR

Placebo granules

Diagnostic Test: Placebo

Interventions

Chinese Herb DRUG

Yinqiaosan-Maxingganshitang granules

Also known as: CM

Active treatment (Yinqiaosan-Maxingganshitang )

Placebo DIAGNOSTIC_TEST

Placebo

Also known as: Plavebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Institute of Integrative Medicine

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 38259270 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ephedrae herba

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhixiu Lin

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: March 28, 2023
• Study Start: May 25, 2023
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

HK (1)