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

NCT ID: NCT05787327

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2024-09-30

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).

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active treatment (Yinqiaosan-Maxingganshitang )

Chinese Medicine granules

Group Type: EXPERIMENTAL

Chinese Herb

Intervention Type: DRUG

Yinqiaosan-Maxingganshitang granules

Placebo

Placebo granules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIAGNOSTIC_TEST

Placebo

Interventions

Chinese Herb

Yinqiaosan-Maxingganshitang granules

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CM; Plavebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhixiu Lin

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Institute of Integrative Medicine

Locations

Hong Kong Institute of Integrative Medicine

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Cho Wing Lo

Role: CONTACT

louislo@cuhk.edu.hk

35053476

Facility Contacts

Zhixiu LIN

Role: primary

28733252

References

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.

Reference Type: DERIVED

PMID: 38259270 (View on PubMed)

Other Identifiers

COVID Acute study

Identifier Type: -

Identifier Source: org_study_id