The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection | NCT04664049

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

NCT04664049

Sponsor

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

Status

Unknown status

Last Update Posted

Jan 13, 2021Actual

Enrollment

51,000Estimated

Phase

Not provided

Conditions

SARS-CoV-2
Covid 19

Interventions

NRICM101

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Dec 4, 2020

First Submission Date that Met QC Criteria

Dec 9, 2020

First Posted Date

Dec 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2021

Last Update Posted Date

Jan 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NRICM101		Subjects who confirmed, suspected or prevented infected of COVID 19 disease and received dietary supplement NRICM101	Dietary Supplement: NRICM101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NRICM101	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi-Chang Su, MD, PhD	Contact	886-2-2820-1999	3101	sychang@nricm.edu.tw
Chien-Jung Lin, MD, PhD	Contact	886-2-8792-3311	12856	linchienjung@yahoo.com

Overall Officials

Name	Affiliation	Role
Yi-Chang Su, MD, PhD	National Research Institute of Chinese Medicine, Ministry of Health and Welfare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Research Institute of Chinese Medicine, Ministry of Health and Welfare	Recruiting	Taipei		11221	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided