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

Sponsor
National Research Institute of Chinese Medicine, Ministry of Health and Welfare (Other)
Overall Status
Recruiting
CT.gov ID
NCT04664049
Collaborator
(none)
51,000
1
24.2
2103.4

Study Details

Study Description

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 Phase
  • 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).

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 23, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. negative of COVID-19 test [1 day to 2 months]

    receive COVID 19 test and the result is negative

  2. free of COVID 19 disease symptoms and signs [1 day to 2 months]

    free of COVID 19 disease symptoms and signs after took NRICM101

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Research Institute of Chinese Medicine, Ministry of Health and Welfare Taipei Taiwan 11221

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Yi-Chang Su, MD, PhD, National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
ClinicalTrials.gov Identifier:
NCT04664049
Other Study ID Numbers:
  • NRICM101
First Posted:
Dec 11, 2020
Last Update Posted:
Jan 13, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2021