Jing-Si-Herbal-Tea Accelerates SARS-Cov-2 Load Reduction Among COVID-19 Patients

Taipei Tzu Chi Hospital,The Buddhist Medical Fundation

Chinese herbal medicine Jing si herbal tea can effectively reduce the expression of SARS CoV2 in the throat of infected patients, provide medical discoveries, formulate effective isolation policies of hospitals and homes, count the virus retention, develop effective medical care and protection of medical personnel, and create a win-win situation.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus
• Intervention / Treatment: Drug: Jing-Si-Herbal-Tea

Detailed Description

Background:

COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2). Studies have pointed out that the traditional Chinese herbal medicine Yinqiao powder has been analyzed by network pharmacology and it may be through Interleukin-6, Mitogen-Activated Protein Kinase 3, Tumor necrosis factor and Tumor protein p53 pathways treat COVID-19 infection [1]. In addition, the clinical case report pointed out that a 38-year-old woman who currently lives in Wuhan was diagnosed by a Chinese physician and given appropriate Chinese herbal medicine. One week later, the patient's symptoms eased and her lungs CT scan showed that her lungs substantive phenomenon has reduction [2].

Aims of the study:

This study is a prospective observational study with the following three purposes.

First, cooperate with the treatment of the domestic temporary diagnosis and treatment guidelines, observe the expression level of the SARS CoV2 virus of the infected patients, and provide the research and development of effective treatment for the future.

Second, observe the clinical information of infected patients and provide effective and reasonable isolation policies in our country.

Third, observe the changes in the expression of the SARS CoV2 virus of the infected patients, and formulate an effective medical personnel protection plan.

Materials and Methods and Innovations:

This study is a prospective observational study with the following three purposes.

First, in accordance with the domestic temporary treatment guidelines, observe the changes in the human immune system and provide research and development of effective future treatments.

Second, using the existing polymerase chain reaction testing equipment of Taipei Tzu Chi hospital to intensively measure the virus negative (Ct ratio :cycle threshold), to observe whether the compound Chinese herbal medicine Jing si herbal tea can effectively reduce the expression of the SARS CoV2 virus in the infected person. Observe the clinical information of infected patients and provide effective and reasonable isolation policies in our country.

Third, the plan for the protection of medical personnel, to detect the contamination of the personnel in the medical care process, the situation of virus retention, and to plan effective medical personnel protection measures.

Expected outcome:

Chinese herbal medicine Jing si herbal tea can effectively reduce the expression of SARS CoV2 in the throat of infected patients, provide medical discoveries, formulate effective isolation policies of hospitals and homes, count the virus retention, develop effective medical care and protection of medical personnel, and create a win-win situation.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yao-Kuang Wu, MD; Phone Number: 886-2-66289779; Email: drbfci@yahoo.com.tw
• Study Contact Backup: Name: Wen-Lin Su, MD; Phone Number: 886-2-66289779; Email: williamsu2007@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 231
    • Recruiting
    • Taipei Tzu chi hospital,The Buddhist medical fundation.
    • Contact: Yao-Kuang Wu, MD; Phone Number: 5709 886-2-66289779; Email: drbfci@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COVID infection patient and age over eighteen

Exclusion Criteria:

• severe pneumonia needing mechanical ventilation
• severe systemic diseases (i.e., malignancy, autoimmune diseases, liver or renal diseases)
• women during pregnancy or lactation
• participation in clinical trials within 3 months
• known allergies to the investigational medications
• other conditions judged by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Jing-Si-Herbal-Tea(JSHT); Eligible patients were randomized to receive routine treatment alone based on the Novel Coronavirus Interim Guidelines for Clinical Management of SARS-CoV-2 Infection (Eleventh edition 2021) (control group) or the combination of routine treatment and JSHT (1 drink thrice daily for 7 days) (JSHT group) at the discretion of the attending clinicians.

Drug: Jing-Si-Herbal-Tea; Eligible patients were randomized to receive routine treatment alone based on the Novel Coronavirus Interim Guidelines for Clinical Management of SARS-CoV-2 Infection (Eleventh edition 2021) (control group) or the combination of routine treatment and JSHT (1 drink thrice daily for 7 days) (JSHT group) at the discretion of the attending clinicians. Routine treatment generally consisted of the supportive treatment such as oxygen therapy, antiviral medications and symptomatic therapies. Adherence to the study medications, clinical outcomes, the use of concomitant medications and adverse events were recorded. The following data were collected at admission: demographics, body mass index, smoking history, comorbidities, CURB-65 Score for pneumonia. Hemogram, laboratory testing, chest X-ray, and nucleic acid assays of SARS-CoV-2 were evaluated at admission and after randomization and on 7th day.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
viral shedding and the decline of acute inflammation	Reverse transcription-polymerase chain reaction Cycle threshold ratio calculation (numerical value) as rising speed and reducing amplitude of C-Reaction protein (mg/dL)	3 months

Collaborators and Investigators

• Sponsor: Yao-Kuang Wu
• Investigators: Principal Investigator: Tzuchi hospital, Taipei TzuChi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: 10-X-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No