Randomized, double-blind, placebo-controlled, multicenter clinical study of Xiaoyao Mixture for the treatment of mild to moderate depression
| ISRCTN | ISRCTN53183053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53183053 |
| Secondary identifying numbers | ChiCTR2300074953 |
- Submission date
- 28/03/2024
- Registration date
- 11/04/2024
- Last edited
- 11/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is a common mental health condition affecting millions of people worldwide. Traditional Chinese Medicine (TCM) has been used for centuries to treat various conditions, including depression. This study aims to evaluate the efficacy and safety of a TCM formula known as Xiaoyao Mixture in treating mild to moderate depression. Our goal is to provide clinical evidence that supports the use of this TCM approach in treating depression.
Who can participate?
Individuals aged 16 to 65 years, of any gender, who have been diagnosed with mild to moderate depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and have a specific score on the Hamilton Depression Rating Scale (HAMD-17) can participate. These participants should also meet the TCM diagnosis for liver stagnation and spleen deficiency syndrome. Participants should be willing to sign an informed consent form and agree to participate in all required visits and treatment checks.
What does the study involve?
Participants will be randomly assigned to either the treatment group or the placebo group. The treatment group will receive Xiaoyao Mixture orally, twice a day, while the placebo group will receive a placebo with the same schedule. The trial includes several visits for assessment and monitoring, during which participants will undergo various health checks and evaluations, including blood and urine tests.
What are the possible benefits and risks of participating?
Participants may not directly benefit from participating in the study. However, the results may help improve the understanding and treatment of depression, benefiting future patients. As with any medication, there may be risks of side effects. Potential risks will be explained in detail prior to participation, and participants are free to withdraw from the study at any time.
Where is the study run from?
The study is being conducted at several sites in China, including Jinan University, Guangzhou, Guangdong Province.
When is the study starting and how long is it expected to run for?
November 2022 to November 2025
Who is funding the study?
The study is funded by a grant from Lunan Hope Pharmaceutical Co., Ltd. (China)
Who is the main contact?
Dr xuan ZHOU, xuetcm@gmail.com
Prof. Jia-xu Chen, chenjiaxu@hotmail.com
Contact information
Principal Investigator
No.601, West Huangpu Avenue
Guangzhou
510632
China
 ORCID ID |
0000-0002-5570-6233 |
|---|---|
| Phone | +86 20 8522 1323 |
| chenjiaxu@hotmail.com |
Public, Scientific
No.601, West Huangpu Avenue
Guangzhou
510632
China
| ORCID ID |
0000-0002-5501-4579 |
|---|---|
| Phone | +86 20 8522 1323 |
| zhoux2019@jnu.edu.cn |
Study information
| Study design | Multicenter interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet". |
| Scientific title | Randomized controlled study on the treatment of mild to moderate depression with Xiaoyao Mixture |
| Study objectives | Xiaoyao Mixture is effective in treating mild to moderate depression compared to a placebo |
| Ethics approval(s) |
Approved 04/11/2022, IRB of Jinan University (No.613, West Huangpu Avenue, Guangzhou, 510632, China; +86 20 8522 0250; oykyc@jnu.edu.cn), ref: JNUKY-2022-100 |
| Health condition(s) or problem(s) studied | Mild to moderate depression |
| Intervention | This study is a prospective, multi-center, double-blinded, randomized controlled trial (RCT) with two parallel arms: XYM group and placebo group. The trial will recruit 72 patients with MMD from 4 hospitals in China, who will be randomly assigned in a 1:1 ratio to receive either XYM (Xiaoyao Mixture), an oral solution, at a dosage of 30 millilitres, two times per day or placebo for 6 weeks. Randomization will be performed using a central, concealed, web-based system, with stratification by site. An independent statistician will generate the allocation sequence. Participants, researchers, and outcome assessors will be blinded to the group assignments. Unblinding will occur only after the trial's conclusion or in case of emergency. |
| Intervention type | Supplement |
| Primary outcome measure | Depression severity measured using Hamilton Depression Rating Scale at baseline, Week 1, Week 2, Week 4 and Week 6. |
| Secondary outcome measures | 1. Anxiety levels measured using Hamilton Anxiety Rating Scale at Week 1, Week 2, Week 4, and Week 6. 2. Anhedonia assessed with Dimensional Anhedonia Rating Scale at Week 1, Week 2, Week 4, and Week 6. 3. Pleasure experience measured using Temporal Experience of Pleasure Scale at Week 1, Week 2, Week 4, and Week 6. 4. Quality of life satisfaction gauged with Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Week 1, Week 2, Week 4, and Week 6. 5. Somatic symptoms measured using Patient Health Questionnaire-15 at Week 6. 6. Sleep quality assessed with Pittsburgh Sleep Quality Index at Week 6. 7. Global functioning evaluated with Clinical Global Impression scale at Week 1, Week 2, Week 4, and Week 6. 8. Traditional Chinese Medicine syndrome evaluated with Liver Depression and Spleen Deficiency Syndrome score at Week 1, Week 2, Week 4, and Week 6. |
| Overall study start date | 04/11/2022 |
| Completion date | 03/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 108 (including 36 healthy volunteers) |
| Key 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 years, regardless of gender; 4. Patients are voluntary, have informed consent, and have good compliance. |
| Key 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 who used fluoxetine within 4 weeks before enrollment; 9. Other situations that the researchers consider unsuitable for participating in this trial. |
| Date of first enrolment | 01/11/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Guangzhou
510120
China
Guangzhou
510632
China
Beijing
100010
China
Ganzhou
341000
China
Sponsor information
University/education
School of Chinese Medicine, No.601, West Huangpu Avenue
Guangzhou
510632
China
| Phone | +86-0531-88382186 |
|---|---|
| yaojingchun@yeah.net | |
| Website | https://www.jnu.edu.cn/main.htm |
"ROR" |
https://ror.org/04bgbsx11 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/05/2025 |
|---|---|
| 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 file | 11/04/2024 | No | No |
Additional files
Editorial Notes
28/03/2024: Trial's existence confirmed by IRB of Jinan University
