Liver-Stagnation and Spleen-DeficiencyPhase 4NCT07590609
Effect of XingpiJieyu Formula on Mitochondrial Energy Metabolism in Severe Liver-Stagnation and Spleen-Deficiency Depression.
A Phase 4 study testing XingpiJieyu Formula (XPJYF) + Escitalopram in people with Liver-Stagnation and Spleen-Deficiency and Severe Major Depression Disorder, run by Peking University Sixth Hospital at 2 sites in China.
Trial summary
Study Title: Research on the therapeutic effect and clinical indicators of XingpiJieyu formula in the treatment of severe liver depression and spleen deficiency type depression based on abnormal mitochondrial energy metabolism pathway Purpose of the Study: (1) Application of XPJYF in the treatment of severe MDD… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver-Stagnation and Spleen-Deficiency, Severe Major Depression Disorder
- What is being tested?
- XingpiJieyu Formula (XPJYF) + Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 23 May 2023to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ① Outpatient/inpatient, aged 18-60, right-handed
- ② The diagnosis of Western medicine meets the diagnostic criteria of DSM-5 for MDD, as well as the diagnostic criteria for depression and liver depression and spleen deficiency in the 2008 Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine issued by the Chinese Society of Traditional Chinese Medicine HAMD-17 score ≥ 18 points, and HAMD-17 item 3 ≤ 2 points
Who cannot join
- DSM-5, with the exception of MDD, has any current or past diagnosis of Axis I mental disorders (MINI). Or it does not meet the diagnostic criteria for depression and liver depression and spleen deficiency syndrome in the "Diagnosis and Treatment Guidelines for Common Diseases in Traditional Chinese Medicine" issued by the Chinese Society of Traditional Chinese Medicine in 2008 ② Education years<5 years or IQ<90 points ③ Suicide ideation or suicidal behavior (HAMD-17 item 3>2 points)
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Sixth Hospital
Beijing, 100191
Peking University Sixth Hospital
Beijing
About this study
Official title: Research on the Therapeutic Effect and Clinical Indicators of XingpiJieyu Formula in the Treatment of Severe Liver Depression and Spleen Deficiency Type Depression Based on Abnormal Mitochondrial Energy Metabolism Pathway
Study Title: Research on the therapeutic effect and clinical indicators of XingpiJieyu formula in the treatment of severe liver depression and spleen deficiency type depression based on abnormal mitochondrial energy metabolism pathway
Purpose of the Study: (1) Application of XPJYF in the treatment of severe MDD patients for 8 weeks, detection of abnormal mitochondrial energy metabolism and biosynthesis, and exploration of biological markers for the therapeutic effect of XPJYF in the treatment of severe MDD with liver depression and spleen deficiency type. (2) Explore the biological indicators for predicting the antidepressant efficacy of XPJYF in the treatment of severe MDD patients and explore new pharmacological pathways for the combination of traditional Chinese and Western medicine in the treatment of MDD.
Read more
To evaluate whether adding Xingpi Jieyu Formula (a traditional Chinese herbal granule) to the standard antidepressant escitalopram improves symptoms in people with severe major depressive disorder (MDD) who also have a specific traditional Chinese medicine pattern called "Liver-Stagnation and Spleen-Deficiency."
Study Design:
100 patients with severe MDD (Liver-Stagnation and Spleen-Deficiency pattern) will be randomly assigned to one of two groups: Test group: Escitalopram + Xingpi Jieyu Formula, Control group: Escitalopram + placebo (identical granules with no active ingredient).
An additional 50 healthy volunteers will serve as a comparison group. Treatment duration: 8 weeks. Double-blind design: neither participants nor study doctors know who receives the real herbal formula or the placebo.
Data Collection Timepoints: Baseline (before treatment), Week 2, and Week 8 (end of treatment). At each timepoint, blood samples and clinical information (e.g., mood ratings, symptom scores) will be collected.
Main Measurements: Blood samples will be tested for markers of mitochondrial energy metabolism (using ELISA). Whole genome testing will be performed in 60 patients (from the MDD groups) and in all 30 healthy volunteers.
Inclusion Criteria: ① Outpatient/inpatient, aged 18-60, right-handed. ② The diagnosis of Western medicine meets the diagnostic criteria of DSM-5 for MDD, as well as the diagnostic criteria for depression and liver depression and spleen deficiency in the 2008 Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine issued by the Chinese Society of Traditional Chinese Medicine HAMD-17 score ≥ 18 points, and HAMD-17 item 3 ≤ 2 points
Exclusion Criteria: ① DSM-5, with the exception of MDD, has any current or past diagnosis of Axis I mental disorders (MINI). Or it does not meet the diagnostic criteria for depression and liver depression and spleen deficiency syndrome in the "Diagnosis and Treatment Guidelines for Common Diseases in Traditional Chinese Medicine" issued by the Chinese Society of Traditional Chinese Medicine in 2008. ② Education years<5 years or IQ<90 points. ③ Suicide ideation or suicidal behavior (HAMD-17 item 3>2 points).
Possible Benefits: May offer a new treatment option for patients with severe depression who do not fully respond to standard antidepressants. May help identify blood markers that can predict which patients are most likely to benefit from adding traditional Chinese medicine to their treatment. May improve understanding of how traditional Chinese medicine affects cellular energy metabolism (mitochondria), potentially leading to better treatments for depression.
Risks and Safety: All study medications (escitalopram and Xingpi Jieyu Formula) are already approved for clinical use. Side effects are known and generally mild. Blood draws may cause temporary discomfort or bruising. Participants will be closely monitored by study doctors. If serious side effects occur, the study medication can be stopped and appropriate medical care will be provided. All personal information and test results will be kept confidential.
Study Location and Approval: This study is led by researchers at Peking University Sixth Hospital (and other collaborating centers) and has been approved by the Medical Ethics Committee.
- Being tested
- XingpiJieyu Formula (XPJYF) + Escitalopram, XingpiJieyu Placebo + Escitalopram
- Keywords
- Liver-Stagnation and Spleen-Deficiency pattern, XingpiJieyu Formula (XPJYF), mitochondria, Integrated Traditional Chinese and Western Medicine, severe MDD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XingpiJieyu Formula (XPJYF) + EscitalopramDrug
XingpiJieyu Formula (XPJYF): Traditional Chinese medicine herbal granules. Dosage: 1 sachet (approximately 5 g) taken orally with 200 ml warm water after meals, twice daily.
Escitalopram: Selective serotonin reuptake inhibitor (SSRI) tablets. Dosage: 10 mg/day for the first week; after one week, the dose may be increased to 10-20 mg/day based on clinical response and tolerability.
Both medications are taken for 8 weeks.
XingpiJieyu Placebo + EscitalopramDrug
XingpiJieyu Placebo: Granules identical in appearance, taste, and administration to Xingpi Jieyu Formula but containing no active pharmaceutical ingredients. Dosage: 1 sachet taken orally with 200 ml warm water after meals, twice daily.
Escitalopram: Same as Arm 1 (10-20 mg/day for 8 weeks).
| Study group | Role | What they receive |
|---|---|---|
| XingpiJieyu Formula + Escitalopram | Experimental | Patients with severe major depressive disorder (Liver-Stagnation and Spleen-Deficiency pattern according to TCM) receive oral escitalopram (10-20 mg/day) combined with XingpiJieyu Formula granules for 8 weeks. Receives: Drug: XingpiJieyu Formula (XPJYF) + Escitalopram |
| XingpiJieyu Placebo + Escitalopram | Placebo comparator | Patients with severe major depressive disorder (Liver-Stagnation and Spleen-Deficiency pattern according to TCM) receive oral escitalopram (10-20 mg/day) combined with a matching placebo for 8 weeks. Receives: Drug: XingpiJieyu Placebo + Escitalopram |
| Healthy Control | No intervention | Age- and sex-matched healthy volunteers receive no medication. They undergo the same blood sample collection and clinical assessments at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRT1 and its mRNA in peripheral blood nucleated cells
Detection of SIRT1 and its mRNA in peripheral blood nucleated cells (particularly PBMCs) at the end of 8 weeks treatment from baseline and compared with healthy control on baseline to test biological effectiveness of XPJYF and ESC in the treatment of MDD.
Measured: Baseline (week 0), week 2, and week 8
Hamilton Depression Rating Scale, 17 items (HAMD-17) total score changes
One hundred MDD patients with treatment - efficacy as assessed by HAMD - 17 on baseline, at the end of 2 weeks and 8 weeks.
Measured: Baseline (week 0), week 2, and week 8
Secondary outcomes (1)
TESS for adverse effect rating
TESS assessment was used to evaluate the adverse effects of XPJYF and ESC treatment in 80 patients with MDD at the end of 2 weeks and 8 weeks of treatment, and the difference in total TESS scores between the two MDD groups (40 patients in each group) was compared.
Measured: Week 2 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start23 May 2023
- Primary completion28 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver-Stagnation and Spleen-DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongfang Hospital Beijing University of Chinese Medicine, National Institute on Drug Dependence, Peking University
- Responsible party
- Principal investigator, Xueqin Wang, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590609
- Sponsor's protocol ID
- MR-11-23-049173
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Therapeutic Effect and Clinical Indicators of XingpiJieyu Formula in the Treatment of Severe Liver Depression and Spleen Deficiency Type Depression Based on Abnormal Mitochondrial Energy Metabolism Pathway
- ClinicalTrials.gov ID
- NCT07590609
- Acronym / sponsor ID
- MR-11-23-049173
- Keywords
- Liver-Stagnation and Spleen-Deficiency pattern, XingpiJieyu Formula (XPJYF), mitochondria, Integrated Traditional Chinese and Western Medicine, severe MDD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Collaborators
- Dongfang Hospital Beijing University of Chinese Medicine, National Institute on Drug Dependence, Peking University
- Study start
- 23 May 2023 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Title: Research on the therapeutic effect and clinical indicators of XingpiJieyu formula in the treatment of severe liver depression and spleen deficiency type depression based on abnormal mitochondrial energy metabolism pathway
Purpose of the Study: (1) Application of XPJYF in the treatment of severe MDD patients for 8 weeks, detection of abnormal mitochondrial energy metabolism and biosynthesis, and exploration of biological markers for the therapeutic effect of XPJYF in the treatment of severe MDD with liver depression and spleen deficiency type. (2) Explore the biological indicators for predicting the antidepressant efficacy of XPJYF in the treatment of severe MDD patients and explore new pharmacological pathways for the combination of traditional Chinese and Western medicine in the treatment of MDD.
To evaluate whether adding Xingpi Jieyu Formula (a traditional Chinese herbal granule) to the standard antidepressant escitalopram improves symptoms in people with severe major depressive disorder (MDD) who also have a specific traditional Chinese medicine pattern called "Liver-Stagnation and Spleen-Deficiency."
Study Design:
100 patients with severe MDD (Liver-Stagnation and Spleen-Deficiency pattern) will be randomly assigned to one of two groups: Test group: Escitalopram + Xingpi Jieyu Formula, Control group: Escitalopram + placebo (identical granules with no active ingredient).
An additional 50 healthy volunteers will serve as a comparison group. Treatment duration: 8 weeks. Double-blind design: neither participants nor study doctors know who receives the real herbal formula or the placebo.
Data Collection Timepoints: Baseline (before treatment), Week 2, and Week 8 (end of treatment). At each timepoint, blood samples and clinical information (e.g., mood ratings, symptom scores) will be collected.
Main Measurements: Blood samples will be tested for markers of mitochondrial energy metabolism (using ELISA). Whole genome testing will be performed in 60 patients (from the MDD groups) and in all 30 healthy volunteers.
Inclusion Criteria: ① Outpatient/inpatient, aged 18-60, right-handed. ② The diagnosis of Western medicine meets the diagnostic criteria of DSM-5 for MDD, as well as the diagnostic criteria for depression and liver depression and spleen deficiency in the 2008 Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine issued by the Chinese Society of Traditional Chinese Medicine HAMD-17 score ≥ 18 points, and HAMD-17 item 3 ≤ 2 points
Exclusion Criteria: ① DSM-5, with the exception of MDD, has any current or past diagnosis of Axis I mental disorders (MINI). Or it does not meet the diagnostic criteria for depression and liver depression and spleen deficiency syndrome in the "Diagnosis and Treatment Guidelines for Common Diseases in Traditional Chinese Medicine" issued by the Chinese Society of Traditional Chinese Medicine in 2008. ② Education years<5 years or IQ<90 points. ③ Suicide ideation or suicidal behavior (HAMD-17 item 3>2 points).
Possible Benefits: May offer a new treatment option for patients with severe depression who do not fully respond to standard antidepressants. May help identify blood markers that can predict which patients are most likely to benefit from adding traditional Chinese medicine to their treatment. May improve understanding of how traditional Chinese medicine affects cellular energy metabolism (mitochondria), potentially leading to better treatments for depression.
Risks and Safety: All study medications (escitalopram and Xingpi Jieyu Formula) are already approved for clinical use. Side effects are known and generally mild. Blood draws may cause temporary discomfort or bruising. Participants will be closely monitored by study doctors. If serious side effects occur, the study medication can be stopped and appropriate medical care will be provided. All personal information and test results will be kept confidential.
Study Location and Approval: This study is led by researchers at Peking University Sixth Hospital (and other collaborating centers) and has been approved by the Medical Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XingpiJieyu Formula + Escitalopram | Experimental | Drug: XingpiJieyu Formula (XPJYF) + EscitalopramPatients with severe major depressive disorder (Liver-Stagnation and Spleen-Deficiency pattern according to TCM) receive oral escitalopram (10-20 mg/day) combined with XingpiJieyu Formula granules for 8 weeks. |
| XingpiJieyu Placebo + Escitalopram | Placebo comparator | Drug: XingpiJieyu Placebo + EscitalopramPatients with severe major depressive disorder (Liver-Stagnation and Spleen-Deficiency pattern according to TCM) receive oral escitalopram (10-20 mg/day) combined with a matching placebo for 8 weeks. |
| Healthy Control | No intervention | –Age- and sex-matched healthy volunteers receive no medication. They undergo the same blood sample collection and clinical assessments at baseline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ① Outpatient/inpatient, aged 18-60, right-handed
- ② The diagnosis of Western medicine meets the diagnostic criteria of DSM-5 for MDD, as well as the diagnostic criteria for depression and liver depression and spleen deficiency in the 2008 Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine issued by the Chinese Society of Traditional Chinese Medicine HAMD-17 score ≥ 18 points, and HAMD-17 item 3 ≤ 2 points
Key exclusion criteria (1 listed)
- DSM-5, with the exception of MDD, has any current or past diagnosis of Axis I mental disorders (MINI). Or it does not meet the diagnostic criteria for depression and liver depression and spleen deficiency syndrome in the "Diagnosis and Treatment Guidelines for Common Diseases in Traditional Chinese Medicine" issued by the Chinese Society of Traditional Chinese Medicine in 2008 ② Education years<5 years or IQ<90 points ③ Suicide ideation or suicidal behavior (HAMD-17 item 3>2 points)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XingpiJieyu Formula (XPJYF) + EscitalopramXingpiJieyu Formula (XPJYF): Traditional Chinese medicine herbal granules. Dosage: 1 sachet (approximately 5 g) taken orally with 200 ml warm water after meals, twice daily. Escitalopram: Selective serotonin reuptake inhibitor (SSRI) tablets. Dosage: 10 mg/day for the first week; after one week, the dose may be increased to 10-20 mg/day based on clinical response and tolerability. Both medications are taken for 8 weeks. | Drug | XingpiJieyu Formula + Escitalopram |
| XingpiJieyu Placebo + EscitalopramXingpiJieyu Placebo: Granules identical in appearance, taste, and administration to Xingpi Jieyu Formula but containing no active pharmaceutical ingredients. Dosage: 1 sachet taken orally with 200 ml warm water after meals, twice daily. Escitalopram: Same as Arm 1 (10-20 mg/day for 8 weeks). | Drug | XingpiJieyu Placebo + Escitalopram |
Primary outcome
SIRT1 and its mRNA in peripheral blood nucleated cells
Time frame: Baseline (week 0), week 2, and week 8
Detection of SIRT1 and its mRNA in peripheral blood nucleated cells (particularly PBMCs) at the end of 8 weeks treatment from baseline and compared with healthy control on baseline to test biological effectiveness of XPJYF and ESC in the treatment of MDD.
Hamilton Depression Rating Scale, 17 items (HAMD-17) total score changes
Time frame: Baseline (week 0), week 2, and week 8
One hundred MDD patients with treatment - efficacy as assessed by HAMD - 17 on baseline, at the end of 2 weeks and 8 weeks.
1 secondary outcome
TESS for adverse effect rating
Time frame: Week 2 and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XingpiJieyu Formula (XPJYF) + Escitalopram in people with Liver-Stagnation and Spleen-Deficiency and Severe Major Depression Disorder, run by Peking University Sixth Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRT1 and its mRNA in peripheral blood nucleated cells (time frame: Baseline (week 0), week 2, and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.