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The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection

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ClinicalTrials.gov Identifier: NCT04664049
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Brief 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. 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).

Condition or disease Intervention/treatment
SARS-CoV-2 Covid 19 Dietary Supplement: NRICM101

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).

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Study Type : Observational
Estimated Enrollment : 51000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
NRICM101
Subjects who confirmed, suspected or prevented infected of COVID 19 disease and received dietary supplement NRICM101
Dietary Supplement: NRICM101

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





Primary Outcome Measures :
  1. negative of COVID-19 test [ Time Frame: 1 day to 2 months ]
    receive COVID 19 test and the result is negative

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101
Criteria

Inclusion Criteria:

  • Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101

Exclusion Criteria:

  • Those who refuse to participate in observational research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664049


Contacts
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Contact: Yi-Chang Su, MD, PhD 886-2-2820-1999 ext 3101 sychang@nricm.edu.tw
Contact: Chien-Jung Lin, MD, PhD 886-2-8792-3311 ext 12856 linchienjung@yahoo.com

Locations
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Taiwan
National Research Institute of Chinese Medicine, Ministry of Health and Welfare Recruiting
Taipei, Taiwan, 11221
Contact: Yi-Chang Su, MD, PhD    886-2-2820-1999 ext 3101    sychang@nricm.edu.tw   
Contact: Chien-Jung Lin, MD, PhD    886-2-8792-3311 ext 12856    linchienjung@yahoo.com   
Sponsors and Collaborators
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Investigators
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Principal Investigator: Yi-Chang Su, MD, PhD National Research Institute of Chinese Medicine, Ministry of Health and Welfare
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Responsible Party: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
ClinicalTrials.gov Identifier: NCT04664049    
Other Study ID Numbers: NRICM101
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Research Institute of Chinese Medicine, Ministry of Health and Welfare:
NRICM101
Covid 19
SARS-CoV-2
Additional relevant MeSH terms:
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Infection