A multi-center, randomized, double-blind, double-simulated, positive drug parallel controlled clinical trial to evaluate the effectiveness and safety of Jiuwei Zhenxin Granules in the treatment of generalized anxiety disorder

Registration number:

ITMCTR2100004826

Date of Last Refreshed on:

2021-01-28

Date of Registration:

2021-01-28

Registration Status:

Retrospective registration

Public title:

A multi-center, randomized, double-blind, double-simulated, positive drug parallel controlled clinical trial to evaluate the effectiveness and safety of Jiuwei Zhenxin Granules in the treatment of generalized anxiety disorder

English Acronym:

Scientific title:

A multi-center, randomized, double-blind, double-simulated, positive drug parallel controlled clinical trial to evaluate the effectiveness and safety of Jiuwei Zhenxin Granules in the treatment of generalized anxiety disorder

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100042771 ; ChiMCTR2100004826

Applicant:

Ji Lianying

Study leader:

Wang Gang

Applicant telephone:

+86 010-62622266

Study leader's telephone:

+86 010-58303182

Applicant Fax:

Study leader's fax:

Applicant E-mail:

jily@beilu.com.cn

Study leader's E-mail:

gangwangdocvip@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

Maples International office, 7th Floor, Block A, 32 North Xizhimen Street, Haidian District, Beijing, China

Study leader's address:

5 Ankang Hutong, Deshengmenwai Street, Xicheng District, Beijing, China

Applicant postcode:

100082

Study leader's postcode:

Applicant's institution:

Beijing BeiLu Pharmaceutical Co., Ltd

Approved by ethic committee:

Approved No. of ethic committee:

(2012)临审第(17)号

Approved file of Ethical Committee:

View

Name of the ethic committee:

The Ethic Committee of Beijing Anding Hospital, Capital Medical University

Date of approved by ethic committee:

2012/8/20 0:00:00

Contact Name of the ethic committee:

Jia Jingjin

Contact Address of the ethic committee:

2nd Floor, Outpatient Building, 5 Ankang Hutong, Deshengmenwai Street, Xicheng District, Beijing

Contact phone of the ethic committee:

+86 010-58303235

Contact email of the ethic committee:

anding_lunli@sina.com

Primary sponsor:

Beijing Anding Hospital, Capital Medical University

Primary sponsor's address:

5 Ankang Hutong, Deshengmenwai Street, Xicheng District, Beijing, China

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Institution
hospital:

Beijing BeiLu Pharmaceutical Co., Ltd

Address:

Maples International office, 7th Floor, Block A, 32 North Xizhimen Street, Haidian District

Source(s) of funding:

Beijing BeiLu Pharmaceutical Co., Ltd

Target disease:

Generalized Anxiety Disorder

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Phase IV clinical trial

Objectives of Study:

To evaluate the effectiveness and safety of Jiuwei Zhenxin Granules in treating generalized anxiety disorder.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Meet the DSM-IV generalized anxiety disorder (GAD) diagnostic criteria; 2. Hamilton Anxiety Scale (HAMA) total score >=14 points, of which the first item of anxiety item score >=2 points; 3. Hamilton Depression Rating Scale (HAMD) rating total score <17 points, and the third suicide item <3 points; 4. Aged from 18 to 70 years old; 5. Volunteer to participate and sign an informed consent form.

Exclusion criteria:

1. Participate in other drug clinical trials within 30 days before the study; 2. Have used Jiuwei Zhenxin Granules at any time in the past; 3. Except for GAD, there are currently any DSM-IV axis I diagnoses; Patients diagnosed with depression in the past 6 months; Patients diagnosed with panic disorder, post-traumatic stress disorder or eating disorder in the past 1 year; Have had obsessive-compulsive disorder, bipolar disorder, schizophrenia, schizoaffective mental disorder, somatoform disorder before; 4. There is a history of Axis II disorder or anti-social behavior, and the investigator judges that it will affect the patient's compliance with the research protocol; 5. According to the DSM-IV-TR criteria, patients have substance abuse or dependence and have not been completely relieved. According to the medical history, the investigator judges that the patient meets the DSM-IV-TR substance-related mental disorder; 6. Alanine aminotransferase (ALT) > 2 times the upper limit of normal; Aspartate aminotransferase (AST)>3 times the upper limit of normal; Total bilirubin (TBIL) > 1.5 times the upper limit of normal; 7. Other serious medical diseases, these diseases will affect the ability of patients to participate in this trial. The right to judge the decision belongs to the investigators; 8. It belongs to secondary anxiety of physical diseases such as thyroid dysfunction, hypertension, coronary heart disease; 9. Have epilepsy or have a history of epilepsy; 10. Patients with narrow-angle glaucoma and increased intraocular pressure. 11. Begin regular psychotherapy or paroxetine treatment within 90 days before baseline; 12. Use antipsychotic drugs, mood stabilizer treatment or MECT treatment within 30 days before baseline; 13. Have used monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days before baseline, or may need to use MAOI during the study or within 14 days of stopping the study drug; 14. Use antidepressants or anti-anxiety drugs within 14 days before baseline; 15. Use traditional Chinese herbal products for anxiety, insomnia or depression, or sedative and hypnotic drugs (except for permitted non-benzodiazepine hypnotics, and do not exceed the dose) within 7 days before baseline; 16. The use of 2 or more antidepressants and/or benzodiazepines in sufficient amounts, that is, treatment with a clinically appropriate dose for at least 4 weeks, but still ineffective; 17. Women who are pregnant or preparing to become pregnant or breast-feeding; 18. Patients who are known to be allergic to or have contraindications to Jiuwei Zhenxin Granules and Paroxetine; 19. Patients with a previous history of leukopenia or lack of white blood cells; 20. Other situations deemed unsuitable by the investigator.

Study execute time:

From 2012-10-10

To      2014-10-28

Recruiting time:

From 2012-10-10

To      2014-10-28

Interventions:

120

Group:

Control group

Sample size:

Intervention:

Paroxetine tablets

Intervention code:

120

Group:

Experimental group

Sample size:

Intervention:

Jiuwei Zhenxin Granules

Intervention code:

Total sample size : 240

Countries of recruitment
and research settings:

Country:

China

Province:

Hebei

City:

Institution/hospital:

The First Hospital of Hebei Medical University

Level of the institution:

Tertiary A

Country:

China

Province:

Shandong

City:

Institution/hospital:

Qilu Hospital of Shandong University

Level of the institution:

Tertiary A

Country:

China

Province:

Beijing

City:

Institution/hospital:

Xuanwu Hospital Capital Medical University

Level of the institution:

Tertiary A

Country:

China

Province:

Beijing

City:

Institution/hospital:

Beijing Chaoyang Hospital Capital Medical University

Level of the institution:

Tertiary A

Country:

China

Province:

Tianjin

City:

Institution/hospital:

Tianjin Anding Hospital

Level of the institution:

Tertiary A

Outcomes:

Outcome:

HAMA total score

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

HAMD score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

QIDS-SR16

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

CGI-I

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Self-rating Anxiety Scale (SAS)

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Pittsburgh Sleep Quality Index Self-Test

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

SF-36

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:

Completed

18
Min age years
70
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

Use the central block randomization, DAS 2.0 software to generate the random number, apply the DAS electronic central randomization system (DAS for IWRS) to apply for the random number and dispense drugs.

Blinding:

Double blind

IPD sharing:

Yes

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

ResMan (www.medresman.org.cn)

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

Case Report Form, CRF

Data Managemen Committee:

No

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