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The randomized double-blind placebo-controlled multicenter clinical study of Xiaoyao Mixture for the treatment of mild to moderate depression

Registration number：

ITMCTR2024000364

Date of Last Refreshed on：

2024-09-03

Date of Registration：

2024-09-03

Registration Status：

Retrospective registration

Public title：

The randomized double-blind placebo-controlled multicenter clinical study of Xiaoyao Mixture for the treatment of mild to moderate depression

English Acronym：

Scientific title：

Clinical Study on the Treatment of Mild to Moderate Depression with Xiaoyao Mixture

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

ZHOU Xuan

Study leader：

CHEN Jiaxu

Applicant telephone：

13128235547

Study leader's telephone：

13910800582

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zhoux2019@jnu.edu.cn

Study leader's E-mail：

chenjiaxu@hotmail.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.601 West Huangpu Avenue guangzhou guangdong

Study leader's address：

No.603 West Huangpu Avenue guangzhou guangdong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jinan University

Approved by ethic committee：

Approved No. of ethic committee：

JNUKY-2022-100

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of Jinan university

Date of approved by ethic committee：

2022/11/4 0:00:00

Contact Name of the ethic committee：

Teacher Li

Contact Address of the ethic committee：

No.613 West Huangpu Avenue guangzhou guangdong

Contact phone of the ethic committee：

+86 20 8522 0250

Contact email of the ethic committee：

oykyc@jnu.edu.cn

Primary sponsor：

Jinan University

Primary sponsor's address：

No.601 West Huangpu Avenue guangzhou guangdong

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

School of Chinese Medicine of Jinan University

Address：

No.601 West Huangpu Avenue

Source(s) of funding：

horizontal project funding

Target disease：

Mild to Moderate Depression

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

1. Explore the efficacy and safety of Xiaoyao Mixture in treating mild to moderate depression. 2. Observe whether Xiaoyao Mixture has a rapid antidepressant effect.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with a HAMD-17 score between 7 and 24 points. (2) Meet the diagnosis criteria for liver depression and spleen deficiency syndrome; (3) Patients aged 16-65 regardless of gender; (4) Patients are voluntary have informed consent and have good compliance.

Exclusion criteria：

(1) Patients with bipolar depression refractory depression or suicidal tendency (item 3 score of HAMD scale > 2 points); (2) Patients with other mental disorders such as organic mental disorders schizophrenia depression disorders caused by psychoactive substances and non-addictive substances; (3) Patients with severe organ lesions such as heart liver and kidney hematological diseases or tumors; (4) Patients who have received systematic treatment within 2 weeks before enrollment; (5) Pregnant or lactating women or those who require fertility during the trial; (6) Patients who are participating in other clinical trials or have participated in other drug clinical trials within 3 months before screening; (7) Patients with a known or suspected allergy to the investigational drugs and excipients or hypersensitivity constitution (defined as allergy to at least 2 drugs); (8) Patients with positive hepatitis B surface antigen (HBsAg) suggested by infectious disease screening during screening period; (9) Patients who used fluoxetine within 4 weeks before enrollment; (10) Other situations that the researchers consider unsuitable for participating in this trial.

Study execute time：

From 2022-11-04

To      2025-11-03

Recruiting time：

From 2023-09-01

To      2025-06-30

Interventions：

36

Group：

Health control

Sample size：

C

Intervention：

No intervention

Intervention code：

36

Group：

Treatment group

Sample size：

A

Intervention：

Xiaoyao Mixture

Intervention code：

36

Group：

Placebo control group

Sample size：

B

Intervention：

Placebo(Xiaoyao mixture simulant)

Intervention code：

Total sample size ： 108

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

Guangdong Province Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

TheFirst Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital)

Level of the institution：

Tertiary A

Country：

China

Province：

Jiangxi

City：

Ganzhou

Institution/hospital：

Ganzhou City people's hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

PHQ-15(Patient Health Questionnaire-15)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

Syndrome score of liver depression and spleen deficiency syndrome

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

SERS(Rating Scale for Side Effects)

Type：

Adverse events

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

DARS(Dimentional Anhedonia Rating Scale)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

C-SSRS(Columbia-Suicide Severity Rating Scale)

Type：

Adverse events

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

PSQI(Pittsburgh sleep quality index)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

HAMA(Hamilton Anxiety Scale)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

Q-LES-Q(Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

CGI(Clinical Global Impressions Scale)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

TEPS(Temporal Experience of Pleasure Scale)

Type：

Secondary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Outcome：

HAMD(Hamilton Depression Scale)

Type：

Primary indicator

Measure time point of outcome：

Week0 Week 1 Week 2 Week 4 Week 6 Week 10

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

16
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The patients were randomized into the Xiaoyao decoction group or the placebo group in a 1:1 ratio using a central randomization system (WindSharp Statistics). Stratified block randomization was used with block size set at 6. The allocation sequence was created by a biostatistician who did not participate in.

Blinding：

Double blind. The allocation sequence was concealed from both researchers and participants until assignment maintaining blinding and integrity. Researchers recruited participants based on predefined criteria and the central system managed the allocation providing pre-coded sealed intervention packages to participants. Pharmacists responsible for labeling the drug packages were not involved in the trial conduct. Independent statisticians unaware of the corresponding interventions will handle the statistical analysis to ensure impartiality.

IPD sharing：

Yes

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

The research data will be published in the form of a paper within 2 years after the completion of clinical trials.

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

Data collection and management includes a CRF and an EDC system.

Data Managemen Committee：

Yes

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

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