A Retrospective Study on the Clinical Application of Compound Huangbai Liquid Topical Solution

Registration number:

ITMCTR2024000310

Date of Last Refreshed on:

2024-08-27

Date of Registration:

2024-08-27

Registration Status:

Retrospective registration

Public title:

A Retrospective Study on the Clinical Application of Compound Huangbai Liquid Topical Solution

English Acronym:

Scientific title:

A Retrospective Study on the Clinical Application of Compound Huangbai Liquid Topical Solution

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

Luo Wenji

Study leader:

Luo Wenji

Applicant telephone:

+86 139 0253 3429

Study leader's telephone:

+86 139 0253 3429

Applicant Fax:

Study leader's fax:

Applicant E-mail:

1018693996@qq.com

Study leader's E-mail:

1018693996@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City, Guangdong Province

Study leader's address:

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City, Guangdong Province

Applicant postcode:

Study leader's postcode:

Applicant's institution:

The Fifth Affiliated Hospital of Sun Yat-sen University

Approved by ethic committee:

Approved No. of ethic committee:

中大五院[2024]伦字第(K143-1)号

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee, The Fifth Affiliated Hospital of Sun Yat-sen University

Date of approved by ethic committee:

2024/5/24 0:00:00

Contact Name of the ethic committee:

Wen Shenglin

Contact Address of the ethic committee:

Room 301, Administrative Complex Building, The Fifth Affiliated Hospital of Sun Yat-sen University, No. 52 Meihua East Road, Xiangzhou District, Zhuhai City, Guangdong Province

Contact phone of the ethic committee:

+86 756 252 8895

Contact email of the ethic committee:

1018693996@qq.com

Primary sponsor:

The Fifth Affiliated Hospital of Sun Yat-sen University

Primary sponsor's address:

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City, Guangdong Province

Secondary sponsor:

Country:

CHINA

Province:

Guangdong province

City:

zhuhai city

Institution
hospital:

The Fifth Affiliated Hospital of Sun Yat-sen University

Address:

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City, Guangdong Province

Source(s) of funding:

Shandong Hanfang Pharmaceutical Co., Ltd

Target disease:

Multiple different diseases

Target disease code:

Study type:

Observational study

Study design:

Case study

Study phase:

Post-marketing clinical trial

Objectives of Study:

The clinical information of patients using compound Phellodenticle liquid coating was retrospectively collected, the clinical characteristics of compound Phellodenticle liquid coating were analyzed, the improvement effects of compound Phellodenticle liquid coating on patients with different diagnoses were evaluated, and the empirical evidence for human use of compound Phellodenticle liquid coating was summarized.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. In the target center: cases of prescription using compound Phellodiscus liquid coating; 2. Age 18-80 years old, male or female.

Exclusion criteria:

The researchers believe that the evaluation of the drug under study is not suitable for the collection of cases.

Study execute time:

From 2024-05-01

To      2025-08-31

Recruiting time:

From 2024-06-01

To      2025-08-31

Interventions:

10000

Group:

Compound Huangbai liquid coating single drug group

Sample size:

Intervention:

None

Intervention code:

Total sample size : 10,000

Countries of recruitment
and research settings:

Country:

CHINA

Province:

Guangdong province

City:

zhuhai city

Institution/hospital:

The Fifth Affiliated Hospital of Sun Yat-sen University

Level of the institution:

Tertiary A

Country:

CHINA

Province:

Guangdong province

City:

shenzhen city

Institution/hospital:

Shenzhen Longgang District Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

Country:

CHINA

Province:

Guangdong province

City:

Guangzhou city

Institution/hospital:

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

Level of the institution:

Tertiary A

Country:

CHINA

Province:

Jiangsu Province

City:

jiangyin city

Institution/hospital:

Jiangyin People's Hospital

Level of the institution:

Tertiary A

Country:

CHINA

Province:

Guangdong province

City:

Guangzhou city

Institution/hospital:

The Eighth Affiliated Hospital of Guangzhou Medical University

Level of the institution:

Tertiary A

Country:

CHINA

Province:

Jiangsu Province

City:

wuxi city

Institution/hospital:

Wuxi maternal and Child Health Care Hospital

Level of the institution:

Tertiary A

Country:

China

Province:

yunnan Province

City:

dali city

Institution/hospital:

Dali First People's Hospital

Level of the institution:

Tertiary A

Country:

CHINA

Province:

Guangdong province

City:

foshan city

Institution/hospital:

Jinan University Affiliated Shunde Hospital

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Blood routine serum procalcitonin (PCT) interleukin-6 (IL-6) C-reactive protein and other tests

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Score of wound edema degree pain score and wound healing time

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

urine

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

Blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
80
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

None

Blinding:

IPD sharing:

Yes

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

http://www.medresman.org.cn/uc/index.aspx

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

EDC

Data Managemen Committee:

Not yet

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