Effects of Jinshui Huanxian granules for patients with PPF:A Multiceter,randomized,double-blind,placebo-controlled trial

Registration number:

ITMCTR2200006437

Date of Last Refreshed on:

2022-08-06

Date of Registration:

2022-08-06

Registration Status:

Prospective registration

Public title:

Effects of Jinshui Huanxian granules for patients with PPF:A Multiceter,randomized,double-blind,placebo-controlled trial

English Acronym:

Scientific title:

Effects of Jinshui Huanxian granules for patients with PPF:A Multiceter,randomized,double-blind,placebo-controlled trial

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200062431 ; ChiMCTR2200006437

Applicant:

Li Bin

Study leader:

Li Jiansheng

Applicant telephone:

199 3710 3286

Study leader's telephone:

137 0371 7893

Applicant Fax:

Study leader's fax:

Applicant E-mail:

libin5563@126.com

Study leader's E-mail:

li_js8@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

19 Renmin Road, Zhengzhou, He'nan, China

Study leader's address:

19 Renmin Road, Zhengzhou, He'nan, China

Applicant postcode:

450000

Study leader's postcode:

450000

Applicant's institution:

The First Affiliated Hospital of He'nan University of CM

Approved by ethic committee:

Approved No. of ethic committee:

2022HL-293-01

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethic Committee of the First Affiliated Hospital of Henan University of CM

Date of approved by ethic committee:

2022/6/24 0:00:00

Contact Name of the ethic committee:

Wang Chunfang

Contact Address of the ethic committee:

19 Renmin Road, Zhengzhou, He'nan, China

Contact phone of the ethic committee:

0371-66285929

Contact email of the ethic committee:

Primary sponsor:

The First Affiliated Hospital of Henan University of CM

Primary sponsor's address:

19 Renmin Road, Zhengzhou, He'nan, China

Secondary sponsor:

Country:

China

Province:

He'nan

City:

Institution
hospital:

Henan University of Chinese Medicine

Address:

156 Jinshui East Road, Zhengzhou, Henan

Source(s) of funding:

Traditional Chinese Medicine Discipline Construction Project of Henan Province's Characteristic Backbone Discipline

Target disease:

Pulmonary fibrosis

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

To evaluate the clinical efficacy and safety of Jinshui Huanxian Decoction in the treatment of PPF patients. To explore the appropriate syndromes of jinshui huangxian decoction in the treatment of PPF patients, so as to provide the basis for further relevant clinical research.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1.Patients diagnosed with PPF;2.Aged 18 or older;3.Comply with TCM syndrome differentiation standards;4.Not participate in any other drug trial within one month prior to enrollment;5.FEV1/FVC≥70% before bronchodilator use;6.FVC% predicted ≥45%;7.Dlco% predicted corrected for normal hemoglobin (Hb) normal ≥ 30%–< 80%;8.Sign informed consent forms.

Exclusion criteria:

1.Patients diagnosed with IPF;2.patients with confused,dementia,various mentally ill people and cannot communicate normally;3.Paitients with acute exacerbation of PPF ;4.Major extra-pulmonary physiologic limitation(eg chest wall abnormalities,massive of pleural effusion);5.Tumor before screening (except localized cancer such as basal cell carcinoma)within 5 year;6.Unstable or worsening heart disease within 6 months prior to screening,including but not limited to the following:myocardial infarction;unstable angina;congestive heart failure (requiring treatment in hospital or NYHA III/IV);uncontrolled severe cardiac arrhythmia;7.TBIL>1.2×ULN,AST or ALT>1.5×ULN;8.CLcr<60ml/min;9.Use of any of the following drugs to treat interstitial lung disease(ILD):strong inducers or strong CYP3A4 inhibitors within 4 weeks before randomization;Azathioprine (AZA),cyclosporine,MMF,combination of tacrolimus,oral corticosteroid(OCS)>20mg/ day,and OCS+AZA+NAC;cyclophosphamide within 8 weeks prior to randomization;Rituximab within 6 months prior to randomization;10.Unable to complete PFT,6MWT,or questionnaire;11.Pregnant or lactating women.

Study execute time:

From 2022-08-01

To      2025-08-01

Recruiting time:

From 2022-08-01

To      2023-08-01

Interventions:

50

Group:

control group

Sample size:

Intervention:

对照组

Intervention code:

50

Group:

experimental group

Sample size:

Intervention:

试验组

Intervention code:

Total sample size : 100

Countries of recruitment
and research settings:

Country:

China

Province:

Henan

City:

Institution/hospital:

Henan Province Hospital of TCM

Level of the institution:

Tertiary A Hospital

Country:

China

Province:

Shandong

City:

Institution/hospital:

Qingdao Traditional Chinese Medicinal Hospital

Level of the institution:

Tertiary A Hospital

Country:

China

Province:

Henan

City:

Institution/hospital:

The First Affiliated Hospital of Henan University of CM

Level of the institution:

Tertiary A Hospital

Country:

China

Province:

Henan

City:

Institution/hospital:

Third Affiliated Hospital of Henan University of Traditional Chinese medicine

Level of the institution:

Tertiary A Hospital

Outcomes:

Outcome:

Annual acute exacerbations

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Annual decline rate of FVC

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

6MWT

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Quality of life

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Progression-free survival

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Severity of dyspnea

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Health-related quality of life

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Clinical symptoms

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

All cause mortality

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:

feces

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

Blood

Tissue:

Fate of sample 

Preservation 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):

A random allocation scheme is formulated by a third party according to a clinical trial plan, and a random distribution scheme is implemented and managed by a central random network allocation system. The clinical trial doctor obtains the assigned patient allocation code by logging in to the Internet

Blinding:

Double blinded

IPD sharing:

Yes

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

Acadimic Papers

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

Case Record Form

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