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
Trial website
Contact information
Type
Scientific
Primary contact
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
Additional contact
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
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
81630104 (National Natural Science Foundation)
Study information
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
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
Trial setting
Hospitals
Trial 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
Phase
Phase IV
Drug names
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 trial start date
30/09/2020
Overall trial end date
30/09/2022
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
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
Locations
Countries of recruitment
China
Trial participating centre
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
613 W. Huangpu Avenue
Guangzhou
510630
China
Trial participating centre
The Affiliated Brain Hospital of Guangzhou Medical University
No.36, Mingxin Road
Fangcun
Liwan District
Guangzhou
510370
China
Trial participating centre
Dongfang Hospital (Beijing University of Chinese Medicine Second Affiliated Hospital)
No. 6 Fangxingyuan 1st Block
Fengtai District
Beijing
100078
China
Trial participating centre
Beijing Anding Hospital Capital Medical University
5 Ankang Hutong
Xicheng District
Beijing
100088
China
Trial participating centre
Peking University Sixth Hospital
No. 51 Hua Yuan Bei Road
Haidian District
Beijing
100191
China
Trial participating centre
Tongde Hospital of Zhejiang Province
No. 234 Gucui Road
Hangzhou
310012
China
Trial participating centre
Beijing University of Chinese Medicine Third Affiliated Hospitail
Chaoyang District Anwai Xiaoguan Street No. 51
Beijing
100029
China
Trial participating centre
Shiyan Hospital of Integrated Traditional Chinese and Western Medicine
No.221 Hanjiang North Road
Shiyan
442010
China
Sponsor information
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
Funders
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, The National Natural Science Foundation of China, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
30/09/2021
Participant level data
Available on request
Basic results (scientific)
Publication list