Evaluation of clinical efficacy of traditional Chinese medicine in promoting nucleic acid conversion of new coronavirus Delta variant strain infection

Registration number:

ITMCTR2100005148

Date of Last Refreshed on:

2021-08-08

Date of Registration:

2021-08-08

Registration Status:

Prospective registration

Public title:

Evaluation of clinical efficacy of traditional Chinese medicine in promoting nucleic acid conversion of new coronavirus Delta variant strain infection

English Acronym:

Scientific title:

Evaluation of clinical efficacy of traditional Chinese medicine in promoting nucleic acid conversion of new coronavirus Delta variant strain infection

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100049663 ; ChiMCTR2100005148

Applicant:

Liu Yuntao

Study leader:

Zhang Zhongde

Applicant telephone:

+86 13560021023

Study leader's telephone:

+86 13903076359

Applicant Fax:

Study leader's fax:

Applicant E-mail:

iamliuyuntao@163.com

Study leader's E-mail:

Doctorzzd99@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Guangdong Provincial Hospital of Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

ZE2021-049-01

Approved file of Ethical Committee:

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

Date of approved by ethic committee:

2021/8/7 0:00:00

Contact Name of the ethic committee:

Li Xiaoyan

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

Secondary sponsor:

Country:

China

Province:

Jiangsu

City:

Nanjing

Institution
hospital:

Jiangsu Provincial Hospital of Chinese Medicine

Address:

155 Hanzhong Road, Qinhuai District

Country:

China

Province:

Jiangsu

City:

Nanjing

Institution
hospital:

The Second Hospital of Nanjing

Address:

1-1 Zhongfu Road, Gulou District

Country:

China

Province:

Guangdong

City:

Guangzhou

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medical

Address:

111 Dade Road, Yuexiu District

Source(s) of funding:

National Administration of Traditional Chinese Medicine

Target disease:

Novel Coronavirus Pneumonia (COVID-19)

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

Based on the standard treatment of western medicine, the effectiveness and safety of fuzheng jiedu granules in promoting nucleic acid negative infection of novel coronavirusDelta mutant strain were evaluated to provide a basis for TCM treatment of novel coronavirusDelta mutant infection.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Meet the diagnostic criteria for COVID-19 (National Eighth Edition); 2. Aged over 18 years; 3. Normal body temperature within 48 hours; 4. In the case of inhaling air, SpO2>93%; 5. Onset time >= 7 days; 6. Sign informed consent.

Exclusion criteria:

1. The nucleic acid test turns negative twice in a row (24 hours apart); 2. Those who meet the discharge criteria and have a positive nucleic acid re-test after discharge; 3. Those who are in critical condition and are expected to die within 24 hours; 4. Abnormal liver and kidney function (more than 2 times the normal value), or a history of severe arrhythmia, heart rate >= 120 beats/min; 5. Allergic to known traditional Chinese medicine; 6. Those who do not cooperate or cannot cooperate with taking traditional Chinese medicine; 7. Pregnant patients.

Study execute time:

From 2021-08-07

To      2022-12-31

Recruiting time:

From 2021-08-07

To      2022-12-31

Interventions:

50

Group:

Control group

Sample size:

Intervention:

Basic treatment

Intervention code:

50

Group:

Experimental group

Sample size:

Intervention:

Basic treatment + Fuzheng detoxification granules

Intervention code:

Total sample size : 100

Countries of recruitment
and research settings:

Country:

China

Province:

Jiangsu

City:

Nanjing

Institution/hospital:

Jiangsu Provincial Hospital of Chinese Medicine

Level of the institution:

Tertiary A

Country:

China

Province:

Jiangsu

City:

Nanjing

Institution/hospital:

The Second Hospital of Nanjing

Level of the institution:

Tertiary A

Outcomes:

Outcome:

The ratio of main symptoms disappeared in 7 days/14 days

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

The change of viral load

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Whether there is a retest positive after the nucleic acid turns negative within 21 days

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Hospital stays

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

7-day/14-day nucleic acid conversion ratio

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

7 days/14 days chest CT imaging changes

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Nucleic acid negative time

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Prognosis

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Blood

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

Saliva

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

Urine

Tissue:

Fate of sample 

Destruction after use

Note:

Not yet recruiting

18
Min age years
Max age years

Recruiting status:

Participant age:

Gender:

Both

Randomization Procedure (please state who generates the random number sequence and by what method):

The central randomization method is used to intervene according to the allocation plan. The treatment plan received by each research subject is determined by the generated random sequence.

Blinding:

Not stated

IPD sharing:

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

August 2022, China Clinical Trial Registration Center

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The most original record is the medical record. The CRF form comes from or partly from the medical record and is filled in by the researcher. Each selected case must complete the CRF form. After the completed CRF form is qualified, it shall be handed over to the data statistics unit for data entry and management.

Data Managemen Committee:

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above