Efficacy and safety of the Xiaoyao pill for improving the clinical symptoms of stagnation of liver qi (chi) and spleen deficiency

Plain English Summary

Background and study aims
Symptoms of depression include loss of interest, loss of sleep and appetite, fatigue and inattention. About 322 million people worldwide suffer from depression, accounting for 4.4% of the world's total population. There are about 54.8 million cases in China, accounting for 4.2% of the Chinese population. In Traditional Chinese Medicine (TCM), the Xiaoyao pill is the fundamental prescription for symptoms of stagnation of liver qi and spleen deficiency. The aim of this study is to assess the effects of the Xiaoyao pill for mild to moderate depression and provide clinical evidence for the biological basis of TCM.

Who can participate?
Patients aged 18-65 with mild to moderate depression

What does the study involve?
Participants are randomly allocated to either the Xiaoyao pill group or the placebo group, receiving either Xiaoyao pill or placebo (dummy pill) twice a day for four consecutive weeks. Depression symptoms are measured at the start of the study and after 2 and 4 weeks. Blood and fecal samples are also collected at the start and the end of treatment to further explore the potential mechanism. This study will take some measures to protect patients from serious adverse events.

What are the possible benefits and risks of participating?
The potential benefit is that depression patients with symptoms of stagnation of liver qi and spleen deficiency may have improved symptoms and quality of life from the Xiaoyao pill treatment. No obvious side effects are documented. During the course of treatment it may be identified that there are some adverse reactions for the patient. This study has procedures in place to safeguard patients. Patients at risk will be counselled by their therapists and signposted to specialist services as appropriate.

Where is the study run from?
Beijing University of Chinese Medicine (China)

When is the study starting and how long is it expected to run for?
September 2020 to September 2022

Who is funding the study?
National Natural Science Foundation (China)

Who is the main contact?
Prof. Jiaxu Chen
xys_clinic2020@163.com

Study website

Type

Scientific

Contact name

Prof Jiaxu Chen

ORCID ID

Contact details

No. 11
Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
+86 (0)10-64286656
xys_clinic2020@163.com

Type

Public

Contact name

Mrs Zhe Xue

ORCID ID

Contact details

No. 11
Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
+86 (0)10-64286656
xuezhesanctity@163.com

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

81630104 (National Natural Science Foundation)

Scientific title

Xiaoyao pill for the treatment of stagnation of liver qi and spleen deficiency with depression: a multi-center randomized controlled double-blind trial

Acronym

Study hypothesis

The trial aims to assess the therapeutic effects of Xiaoyao pill for mild to moderate depression. The aim is to provide clinical evidence for the biological basis of traditional Chinese medicine (TCM).

Ethics approval(s)

Approved 04/06/2020, Ethics Committee of Beijing University of Chinese Medicine (No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing,100029, China; +86 (0)10 53911431;bucmyxll@126.com), ref: 2020BZYLL0304

Study design

Multi-centre double-blinded randomized placebo-controlled parallel clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mild to moderate depression with symptoms of stagnation of liver qi and spleen deficiency

Intervention

The 108 eligible participants will be allocated to the experimental or placebo arm based on a random lottery. Participants will be required to take the medicine twice daily for four consecutive weeks and the dosage is 9 g twice a day.

The experimental intervention is the Xiaoyao pill. Xiaoyao pills are water honey pills (Z20013060) produced by Jiuzhitang Co., Ltd. The appearance and specifications of the placebo are the same as Xiaoyao pills.

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Phase IV

Drug/device/biological/vaccine name(s)

Xiaoyao pill

Primary outcome measure

Depression with symptoms of stagnation of liver qi and spleen deficiency, assessed using the Hamilton Depression scale (HAMD) at baseline, 1 week, 2 weeks and 4 weeks

Secondary outcome measures

Overall health measured using TCM symptoms Scale at baseline, 1 week, 2 weeks and 4 weeks

Overall study start date

30/09/2020

Overall study end date

30/09/2022

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Meet the Diagnostic Statistics Manual of Mental Disorders (DSM-5) regarding the diagnosis of mild to moderate depression
2. A score between 20 and 35 on HAMD
3. Meet the TCM criteria of liver depression and spleen deficiency syndrome
4. Aged between 16 - 18 years old, both genders
5. Patients agree to participate in this trial and assign the informed consent
6. Capable of reading and follow-up treatment, and permanently live locally

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

108

Participant exclusion criteria

1. Bipolar depression,treatment-resistant depression and severe suicidal risk
2. History of bipolar disorder, schizophrenia, obvious psychotic symptoms and depression disorder caused by non-addictive substances
3. Combine with severe cardiovascular diseases, cerebrovascular diseases, hepatic diseases, renal diseases, hematological disease, cancer, or other severe primary diseases
4. Pregnant or lactating women
5. Inability to finish the compliance test, judge the efficacy and have complete data
6. Involved with any other clinical trial at the time of consent

Recruitment start date

30/10/2020

Recruitment end date

30/12/2021

Countries of recruitment

China

Study participating centre

The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
613 W. Huangpu Avenue
Guangzhou
510630
China

Study participating centre

The Affiliated Brain Hospital of Guangzhou Medical University
No.36, Mingxin Road
Fangcun
Liwan District
Guangzhou
510370
China

Study participating centre

Dongfang Hospital (Beijing University of Chinese Medicine Second Affiliated Hospital)
No. 6 Fangxingyuan 1st Block
Fengtai District
Beijing
100078
China

Study participating centre

Beijing Anding Hospital Capital Medical University
5 Ankang Hutong
Xicheng District
Beijing
100088
China

Study participating centre

Peking University Sixth Hospital
No. 51 Hua Yuan Bei Road
Haidian District
Beijing
100191
China

Study participating centre

Tongde Hospital of Zhejiang Province
No. 234 Gucui Road
Hangzhou
310012
China

Study participating centre

Beijing University of Chinese Medicine Third Affiliated Hospitail
Chaoyang District Anwai Xiaoguan Street No. 51
Beijing
100029
China

Study participating centre

Shiyan Hospital of Integrated Traditional Chinese and Western Medicine
No.221 Hanjiang North Road
Shiyan
442010
China

Organisation

Beijing University of Chinese Medicine

Sponsor details

No. 11
Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
+86 (0)10 64286491
bucmkejichu@126.com

Sponsor type

University/education

Website

http://www.bucm.edu.cn/

Funder type

Government

Funder name

National Natural Science Foundation of China

Alternative name(s)

Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

China

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

Intention to publish date

30/09/2021

Individual participant data (IPD) sharing plan

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

IPD sharing plan summary

Available on request

Study outputs