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Study on the intervention of Wenqing Decoction plus or minus steam bath therapy combined with Chinese medicine coating on patients with blood hot air dryness psoriasis

Registration number：

ITMCTR2200006129

Date of Last Refreshed on：

2022-06-14

Date of Registration：

2022-06-14

Registration Status：

Prospective registration

Public title：

Study on the intervention of Wenqing Decoction plus or minus steam bath therapy combined with Chinese medicine coating on patients with blood hot air dryness psoriasis

English Acronym：

Scientific title：

Study on the intervention of Wenqing Decoction plus or minus steam bath therapy combined with Chinese medicine coating on patients with blood hot air dryness psoriasis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200060970 ; ChiMCTR2200006129

Applicant：

Wei Yehong

Study leader：

Wei Yehong

Applicant telephone：

13588178720

Study leader's telephone：

13588178720

Applicant Fax：

Study leader's fax：

Applicant E-mail：

215248222@qq.com

Study leader's E-mail：

215248222@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

502, Unit 1, 20 Macheng Road, Hangzhou City, Zhejiang Province, China

Study leader's address：

502, Unit 1, 20 Macheng Road, Hangzhou City, Zhejiang Province, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

the Second Affiliated Hospital of Zhejiang Chinese Medical University

Approved by ethic committee：

Approved No. of ethic committee：

2021-KL-050-1H01

Approved file of Ethical Committee：

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Zhejiang University of Chinese Medicine

Date of approved by ethic committee：

2021/12/10 0:00:00

Contact Name of the ethic committee：

Zhang Shuo

Contact Address of the ethic committee：

318 Chaowang Road, Hangzhou City, Zhejiang Province, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

the Second Affiliated Hospital of Zhejiang Chinese Medical University

Primary sponsor's address：

the Second Affiliated Hospital of Zhejiang Chinese Medical University

Secondary sponsor：

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution
hospital：

the Second Affiliated Hospital of Zhejiang Chinese Medical University

Address：

318 Chaowang Road, Hangzhou City, Zhejiang Province, China

Source(s) of funding：

self-raised

Target disease：

银屑病

Target disease code：

Study type：

Interventional study

Study design：

Cross-sectional

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

We hope to observe the curative effect of wenqing Decoction plus or less steam bath on the treatment of blood hot wind dryness psoriasis through this study, in order to provide effective, economic and practical treatment for this kind of patients, and widely promoted in clinical practice.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Aged between 18 and 60;In line with the diagnostic criteria of traditional Chinese and Western medicine for psoriasis;Clear consciousness, can cooperate with clinical data collection;TCM syndrome differentiation is blood hot air dryness type;Voluntarily participate in this study and sign informed consent.

Exclusion criteria：

Systematic use of glucocorticoids or immunosuppressants within the last 3 months;Patients with primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and immune system;Pregnant, menstruating and lactating women;Patients with acute infectious diseases;Open wound infectious lesions, too old or physically weak;Allergic to Chinese medicine decoction.

Study execute time：

From 2022-06-01

To      2023-12-31

Recruiting time：

From 2022-06-01

To      2023-12-31

Interventions：

40

Group：

The experimental group

Sample size：

Intervention：

Avia capsule 25mg daily oral based on wenqing drink plus steam bath treatment

Intervention code：

40

Group：

The control group

Sample size：

Intervention：

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

China

Province：

Zhejiang

City：

Institution/hospital：

the Second Affiliated Hospital of Zhejiang Chinese Medical University

Level of the institution：

sanjia

Outcomes：

Outcome：

PASI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

PASI

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

A statistician not involved in the study put the random code into a sealed, opaque file and labeled it.Group members keep the files.When patients who met the diagnostic criteria were enrolled in the study, a file was opened and team members recorded the code.Patients with the same code were assigned&#32

Blinding：

IPD sharing：

Yes

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

Paper published

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

EXCEL

Data Managemen Committee：

Not yet

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

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