SARS-CoV-2NCT04664049
The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection
An observational study of SARS-CoV-2 and Covid 19, run by National Research Institute of Chinese Medicine, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Covid 19
- What is being tested?
- NRICM101
- How many people
- 51,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Dec 2020to 31 Dec 2022
- 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: Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101
Who may be able to join
- Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101
Who cannot join
- Those who refuse to participate in observational research.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Taipei, 11221
Yi-Chang Su, MD, PhD, 886-2-2820-1999 ext. 3101, sychang@nricm.edu.tw
Chien-Jung Lin, MD, PhD, 886-2-8792-3311 ext. 12856, linchienjung@yahoo.com
About this study
Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).
Read the detailed description
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is raging around the world. Because of its strong spread, variability, survivability, and invisibility, the number of infected people rise rapidly. On March 11, 2020, the WHO officially declared COVID-19 as a pandemic disease. As of October 3, 2020, the number of confirmed cases has exceeded 34 million, and the cumulative deaths have exceeded 1 million. There are still no drugs to treatment the coronavirus disease 2019 (COVID-19). Due to the mutation of virus rapidly, vaccine development cannot be completed in a short period of time. At the beginning of the infection outbreak, the governments of China and South Korea, adopted a cooperative of Chinese and Western medicine to treatment the coronavirus disease 2019 (COVID-19). In addition to the reported good clinical effects, Chinese medicine prescriptions have included in diagnosis and treatment guideline of these two countries.
Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).
- Conditions
- SARS-CoV-2, Covid 19
- Being tested
- NRICM101
- Keywords
- NRICM101, Covid 19, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRICM101Dietary supplement
Direction: Take 1 sachet 2-4 times daily directly or with 400cc water before or between meals
Indication: Externally contracted seasonal epidemic
Function: Relieving Exterior and Facilitating Lung, clear heat of lung, Wide chest and resolve phlegm
| Study group | Role | What they receive |
|---|---|---|
| NRICM101 | Subjects who confirmed, suspected or prevented infected of COVID 19 disease and received dietary supplement NRICM101 Receives: Dietary Supplement: NRICM101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative of COVID-19 test
receive COVID 19 test and the result is negative
Measured: 1 day to 2 months
free of COVID 19 disease symptoms and signs
free of COVID 19 disease symptoms and signs after took NRICM101
Measured: 1 day to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start23 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 51,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Institute of Chinese Medicine, Ministry of Health and Welfare
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yi-Chang Su, MD, PhD, Principal investigator, National Research Institute of Chinese Medicine, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664049
- Sponsor's protocol ID
- NRICM101
- Status last verified
- Jan 2021
- First submitted
- 4 Dec 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT04664049
- Acronym / sponsor ID
- NRICM101
- Conditions
- SARS-CoV-2, Covid 19
- Keywords
- NRICM101, Covid 19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51,000 participants (estimated)
- Lead sponsor
- National Research Institute of Chinese Medicine, Ministry of Health and WelfareOther government
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Dec 2020 (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.
Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).
Detailed description
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is raging around the world. Because of its strong spread, variability, survivability, and invisibility, the number of infected people rise rapidly. On March 11, 2020, the WHO officially declared COVID-19 as a pandemic disease. As of October 3, 2020, the number of confirmed cases has exceeded 34 million, and the cumulative deaths have exceeded 1 million. There are still no drugs to treatment the coronavirus disease 2019 (COVID-19). Due to the mutation of virus rapidly, vaccine development cannot be completed in a short period of time. At the beginning of the infection outbreak, the governments of China and South Korea, adopted a cooperative of Chinese and Western medicine to treatment the coronavirus disease 2019 (COVID-19). In addition to the reported good clinical effects, Chinese medicine prescriptions have included in diagnosis and treatment guideline of these two countries.
Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRICM101 | – | Dietary Supplement: NRICM101Subjects who confirmed, suspected or prevented infected of COVID 19 disease and received dietary supplement NRICM101 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101
Key inclusion criteria (1 listed)
- Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101
Key exclusion criteria (1 listed)
- Those who refuse to participate in observational research.
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 |
|---|---|---|
| NRICM101Direction: Take 1 sachet 2-4 times daily directly or with 400cc water before or between meals Indication: Externally contracted seasonal epidemic Function: Relieving Exterior and Facilitating Lung, clear heat of lung, Wide chest and resolve phlegm | Dietary supplement | NRICM101 |
Primary outcome
negative of COVID-19 test
Time frame: 1 day to 2 months
receive COVID 19 test and the result is negative
free of COVID 19 disease symptoms and signs
Time frame: 1 day to 2 months
free of COVID 19 disease symptoms and signs after took NRICM101
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Yi-Chang Su, MD, PhD principal investigator
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
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 SARS-CoV-2 and Covid 19, run by National Research Institute of Chinese Medicine, Ministry of Health and Welfare 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 1 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 13 Jan 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 Yi-Chang Su, MD, PhD (886-2-2820-1999 ext. 3101, sychang@nricm.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative of COVID-19 test (time frame: 1 day to 2 months). The study lists 2 primary outcomes in all. 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 13 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.