Efficacy and safety of the Xiaoyao pill for improving the clinical symptoms of stagnation of liver qi (chi) and spleen deficiency
| ISRCTN | ISRCTN12746343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12746343 |
| Secondary identifying numbers | 81630104 (National Natural Science Foundation) |
- Submission date
- 17/09/2020
- Registration date
- 24/09/2020
- Last edited
- 31/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
No. 11, Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
| Phone | +86 (0)10-64286656 |
|---|---|
| xys_clinic2020@163.com |
Public
No. 11, Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
| Phone | +86 (0)10-64286656 |
|---|---|
| xuezhesanctity@163.com |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 108 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/10/2020 |
| Date of final enrolment | 30/12/2021 |
Locations
Countries of recruitment
- China
Study participating centres
Guangzhou
510630
China
Fangcun
Liwan District
Guangzhou
510370
China
Fengtai District
Beijing
100078
China
Xicheng District
Beijing
100088
China
Haidian District
Beijing
100191
China
Hangzhou
310012
China
Beijing
100029
China
Shiyan
442010
China
Sponsor information
University/education
No. 11, Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
| Phone | +86 (0)10 64286491 |
|---|---|
| bucmkejichu@126.com | |
| Website | http://www.bucm.edu.cn/ |
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- China
Results and Publications
| Intention to publish date | 30/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 04/01/2022 | 07/11/2023 | Yes | No | |
| Results article | 20/04/2024 | 31/05/2024 | Yes | No |
Editorial Notes
31/05/2024: Publication reference added.
07/11/2023: Publication reference added.
21/09/2020: Trial’s existence confirmed by Ethics Committee of Beijing University of Chinese Medicine.
