Jing-Si-Herbal-Tea Accelerates SARS-Cov-2 Load Reduction Among COVID-19 Patients
Primary Purpose
Coronavirus
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Jing-Si-Herbal-Tea
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus
Eligibility Criteria
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.
Sites / Locations
- Taipei Tzu chi hospital,The Buddhist medical fundation.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jing-Si-Herbal-Tea(JSHT)
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967755
Brief Title
Jing-Si-Herbal-Tea Accelerates SARS-Cov-2 Load Reduction Among COVID-19 Patients
Official Title
Taipei Tzu Chi Hospital,The Buddhist Medical Fundation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yao-Kuang Wu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one group received ordinal treatment and other group combination Jing-Si-Herbal-Tea and ordinal treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jing-Si-Herbal-Tea(JSHT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Jing-Si-Herbal-Tea
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
viral shedding and the decline of acute inflammation
Description
Reverse transcription-polymerase chain reaction Cycle threshold ratio calculation (numerical value) as rising speed and reducing amplitude of C-Reaction protein (mg/dL)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao-Kuang Wu, MD
Phone
886-2-66289779
Email
drbfci@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Lin Su, MD
Phone
886-2-66289779
Email
williamsu2007@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzuchi hospital
Organizational Affiliation
Taipei Tzuchi hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Tzu chi hospital,The Buddhist medical fundation.
City
Taipei
ZIP/Postal Code
231
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao-Kuang Wu, MD
Phone
886-2-66289779
Ext
5709
Email
drbfci@yahoo.com.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Jing-Si-Herbal-Tea Accelerates SARS-Cov-2 Load Reduction Among COVID-19 Patients
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