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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664049
• Other study ID #: NRICM101
• Status: Recruiting
• Start date: December 23, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
• Contact: Yi-Chang Su, MD, PhD
• Phone: 886-2-2820-1999
• Email: sychang[@]nricm.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid 19
• Infection
• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Research Institute of Chinese Medicine, Ministry of Health and Welfare	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	negative of COVID-19 test	receive COVID 19 test and the result is negative	1 day to 2 months
Primary	free of COVID 19 disease symptoms and signs	free of COVID 19 disease symptoms and signs after took NRICM101	1 day to 2 months