CoronavirusNCT04967755
Jing-Si-Herbal-Tea Accelerates SARS-Cov-2 Load Reduction Among COVID-19 Patients
A study testing Jing-Si-Herbal-Tea in people with Coronavirus, run by Yao-Kuang Wu at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- Jing-Si-Herbal-Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID infection patient and age over eighteen
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu chi hospital,The Buddhist medical fundation.
Taipei, 231
Yao-Kuang Wu, MD, 886-2-66289779 ext. 5709, drbfci@yahoo.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronavirus
- Being tested
- Jing-Si-Herbal-Tea
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing-Si-Herbal-TeaDrug
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Jing-Si-Herbal-Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Jun 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one group received ordinal treatment and other group combination Jing-Si-Herbal-Tea and ordinal treatment
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yao-Kuang Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yao-Kuang Wu, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Tzuchi hospital, Principal investigator, Taipei Tzuchi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967755
- Sponsor's protocol ID
- 10-X-045
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Tzu Chi Hospital,The Buddhist Medical Fundation
- ClinicalTrials.gov ID
- NCT04967755
- Acronym / sponsor ID
- 10-X-045
- Conditions
- Coronavirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yao-Kuang WuUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one group received ordinal treatment and other group combination Jing-Si-Herbal-Tea and ordinal treatment
| Arm | Type | Receives |
|---|---|---|
| Jing-Si-Herbal-Tea(JSHT) | Experimental | Drug: Jing-Si-Herbal-TeaEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID infection patient and age over eighteen
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing-Si-Herbal-TeaAlso: ControlEligible 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. | Drug | Jing-Si-Herbal-Tea(JSHT) |
Primary outcome
viral shedding and the decline of acute inflammation
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzuchi hospital principal investigator
Taipei Tzuchi hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jing-Si-Herbal-Tea in people with Coronavirus, run by Yao-Kuang Wu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao-Kuang Wu, MD (886-2-66289779, drbfci@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viral shedding and the decline of acute inflammation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.