COVID-19 PandemicNCT05236309
Investigation on the Epidemic Prevention Effect of Using Chinese Medicine During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Outbreak.
An observational study of COVID-19 Pandemic, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Taking a regional hospital as an example, the investigators will discuss the changes in the community cumulative incidence rate(CIR) and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Jing-Guan-Fang(JGF) : Chinese herbal decoction
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 18 Nov 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The subjects of this study are patients who went to the Taipei City Hospital Linsen Chinese Medicine and Kunming Branch from January 1, 2020, to July 31, 2021. It is estimated that the medical records of 1,000 patients who use traditional Chinese medicine for new coronary pneumonia prevention and control will be collected as the experimental group, and they will be randomly matched. The medical records of 1,000 patients who have not used Chinese medicine as a control group for the prevention of new coronary pneumonia, a total of 2,000.
Who may be able to join
- From January 1, 2020 to July 31, 2021, Chinese medicine is used for patients with new coronary pneumonia epidemic prevention.
Who cannot join
- Patients who do not use traditional Chinese medicine for the prevention of new coronary pneumonia.
- Patients who have signed and refused to provide medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taipei City Hospital Linsen Chinese Medicine and Kunming Branch
Taking a regional hospital as an example, the investigators will discuss the changes in the community cumulative incidence rate(CIR) and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak.
Main purpose:
Retrospective case study to explore the effect of traditional Chinese medicine on the prevention of SARS-CoV-2.
Secondary purpose:
If there are related side effects after taking Chinese medicine.
Read the detailed description
The large-scale coronavirus epidemic is a major global public health challenge in the 21st century. Since the 2003 Severe acute respiratory syndrome (SARS) epidemic spread globally and caused hundreds of deaths, the Middle East respiratory syndrome (Middle East respiratory syndrome, MERS) and coronavirus disease 2019(COVID-19) has caused a large-scale global spread and also caused a huge impact on the public health and medical system. In the country's current epidemic (Aug 1, 2021), more than 15,000 people have been diagnosed, and the number of deaths has exceeded 800. Among them, the Taipei epidemic is the most severe, and the Wanhua District of Taipei City is the hot zone. The investigators will discuss the changes in accumulation incidence rate(CIR) of the community and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak.
This is a retrospective case study to explore the effect of traditional Chinese medicine on the prevention of SARS-CoV-2 and discuss if there are related side effects after taking Chinese medicine.
- Conditions
- COVID-19 Pandemic
- Being tested
- Jing-Guan-Fang(JGF) : Chinese herbal decoction
- Keywords
- Chinese medicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing-Guan-Fang(JGF) : Chinese herbal decoctionDrug
Also called Chinese herbal decoction
Use 100ml JGF decoction per day as a preventive measure for patients with COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| JGF (Jing-Guan-Fang): Traditional Chinese Medicine Decoction | JGF group: 100ml JGF decoction per day at least 1 week Receives: Drug: Jing-Guan-Fang(JGF) : Chinese herbal decoction | |
| NO JGF | NO JGF group: None use traditional Chinese medicine(JGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation on the effect of using traditional Chinese medicine to prevent SARS-CoV-2 infection in two groups with cumulative incidence rate(CIR).
Compare the dangerous states within two groups with CIR.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jan 2020
- Primary completion31 Jul 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236309
- Sponsor's protocol ID
- TCHIRB-11009019-E
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei City Hospital Linsen Chinese Medicine and Kunming Branch
- ClinicalTrials.gov ID
- NCT05236309
- Acronym / sponsor ID
- TCHIRB-11009019-E
- Conditions
- COVID-19 Pandemic
- Keywords
- Chinese medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 11 Feb 2022 (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.
Taking a regional hospital as an example, the investigators will discuss the changes in the community cumulative incidence rate(CIR) and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak.
Main purpose:
Retrospective case study to explore the effect of traditional Chinese medicine on the prevention of SARS-CoV-2.
Secondary purpose:
If there are related side effects after taking Chinese medicine.
Detailed description
The large-scale coronavirus epidemic is a major global public health challenge in the 21st century. Since the 2003 Severe acute respiratory syndrome (SARS) epidemic spread globally and caused hundreds of deaths, the Middle East respiratory syndrome (Middle East respiratory syndrome, MERS) and coronavirus disease 2019(COVID-19) has caused a large-scale global spread and also caused a huge impact on the public health and medical system. In the country's current epidemic (Aug 1, 2021), more than 15,000 people have been diagnosed, and the number of deaths has exceeded 800. Among them, the Taipei epidemic is the most severe, and the Wanhua District of Taipei City is the hot zone. The investigators will discuss the changes in accumulation incidence rate(CIR) of the community and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak.
This is a retrospective case study to explore the effect of traditional Chinese medicine on the prevention of SARS-CoV-2 and discuss if there are related side effects after taking Chinese medicine.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JGF (Jing-Guan-Fang): Traditional Chinese Medicine Decoction | – | Drug: Jing-Guan-Fang(JGF) : Chinese herbal decoctionJGF group: 100ml JGF decoction per day at least 1 week |
| NO JGF | – | –NO JGF group: None use traditional Chinese medicine(JGF) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects of this study are patients who went to the Taipei City Hospital Linsen Chinese Medicine and Kunming Branch from January 1, 2020, to July 31, 2021. It is estimated that the medical records of 1,000 patients who use traditional Chinese medicine for new coronary pneumonia prevention and control will be collected as the experimental group, and they will be randomly matched. The medical records of 1,000 patients who have not used Chinese medicine as a control group for the prevention of new coronary pneumonia, a total of 2,000.
Key inclusion criteria (1 listed)
- From January 1, 2020 to July 31, 2021, Chinese medicine is used for patients with new coronary pneumonia epidemic prevention.
Key exclusion criteria (2 listed)
- Patients who do not use traditional Chinese medicine for the prevention of new coronary pneumonia.
- Patients who have signed and refused to provide medical records.
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-Guan-Fang(JGF) : Chinese herbal decoctionAlso: Chinese herbal decoctionUse 100ml JGF decoction per day as a preventive measure for patients with COVID-19. | Drug | JGF (Jing-Guan-Fang): Traditional Chinese Medicine Decoction |
Primary outcome
Investigation on the effect of using traditional Chinese medicine to prevent SARS-CoV-2 infection in two groups with cumulative incidence rate(CIR).
Time frame: 18 months
Compare the dangerous states within two groups with CIR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic, run by Taipei City Hospital 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 2 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: finished, as of the sponsor's last update on 2 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation on the effect of using traditional Chinese medicine to prevent SARS-CoV-2 infection in two groups with cumulative incidence rate(CIR). (time frame: 18 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 2 Mar 2022.