NCT04967755

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 13, 2021

Last Update Submit

July 18, 2021

Conditions

Coronavirus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Jing-Si-Herbal-Tea(JSHT)

EXPERIMENTAL

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

Interventions

Jing-Si-Herbal-TeaDRUG

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.

Also known as: Control
Jing-Si-Herbal-Tea(JSHT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COVID infection patient and age over eighteen

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu chi hospital,The Buddhist medical fundation.

Taipei, 231, Taiwan

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Tzuchi hospital

    Taipei Tzuchi hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao-Kuang Wu, MD

CONTACT

886-2-66289779drbfci@yahoo.com.tw

Wen-Lin Su, MD

CONTACT

886-2-66289779williamsu2007@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: one group received ordinal treatment and other group combination Jing-Si-Herbal-Tea and ordinal treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of division of pulmonary and critical care care medicine

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 20, 2021

Study Start

June 1, 2021

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)