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

Sponsor
Yao-Kuang Wu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04967755
Collaborator
(none)
200
1
1
4
50.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
one group received ordinal treatment and other group combination Jing-Si-Herbal-Tea and ordinal treatmentone group received ordinal treatment and other group combination Jing-Si-Herbal-Tea and ordinal treatment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Taipei Tzu Chi Hospital,The Buddhist Medical Fundation
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. viral shedding and the decline of acute inflammation [3 months]

      Reverse transcription-polymerase chain reaction Cycle threshold ratio calculation (numerical value) as rising speed and reducing amplitude of C-Reaction protein (mg/dL)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Tzu chi hospital,The Buddhist medical fundation. Taipei Taiwan 231

    Sponsors and Collaborators

    • Yao-Kuang Wu

    Investigators

    • Principal Investigator: Tzuchi hospital, Taipei Tzuchi hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yao-Kuang Wu, Director of division of pulmonary and critical care care medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    ClinicalTrials.gov Identifier:
    NCT04967755
    Other Study ID Numbers:
    • 10-X-045
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Jul 20, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2021