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

NCT ID: NCT04664049

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 51000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2022-12-31

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).

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

NRICM101

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

NRICM101

Intervention Type: DIETARY_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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Chang Su, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Locations

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yi-Chang Su, MD, PhD

Role: CONTACT

sychang@nricm.edu.tw

886-2-2820-1999 ext. 3101

Chien-Jung Lin, MD, PhD

Role: CONTACT

linchienjung@yahoo.com

886-2-8792-3311 ext. 12856

Facility Contacts

Yi-Chang Su, MD, PhD

Role: primary

sychang@nricm.edu.tw

886-2-2820-1999 ext. 3101

Chien-Jung Lin, MD, PhD

Role: backup

linchienjung@yahoo.com

886-2-8792-3311 ext. 12856

Other Identifiers

NRICM101

Identifier Type: -

Identifier Source: org_study_id