Anxiety SymptomNCT06921512
TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms
A study testing TCM Daoyin exercise in people with Anxiety Symptom and Depression Symptom, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This 12-week single-arm clinical trial investigates the effects of Traditional Chinese Medicine (TCM) Daoyin exercise on anxiety and depression symptoms in 20 participants, followed by a 12-week observational follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Symptom, Depression Symptom
- What is being tested?
- TCM Daoyin exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary symptoms of anxiety and depression, with a Hamilton Anxiety Rating Scale (HAMA-14) score between 14 and 29 and a Hamilton Depression Rating Scale (HAMD-17) score between 7 and 14.
- No prior use of psychotropic medication, or at least six months since discontinuation.
- Aged 18 to 65 years (male or female).
- Clear consciousness and normal cognitive function, with the ability to communicate effectively, read, express thoughts, and engage in daily activities independently.
- Willing and able to comply with blood and stool sample collection.
- Voluntary participation, with signed informed consent provided before enrollment.
Who cannot join
- Diagnosed anxiety disorder or depressive disorder based on ICD-10 criteria.
- Bipolar disorder, psychotic disorders (e.g., schizophrenia), or organic mental disorders (e.g., Alzheimer's disease).
- History of alcohol or substance use disorder within the past year, current psychiatric medication use, or high suicide risk.
- Severe or unstable medical conditions, including immune or endocrine disorders or other serious illnesses.
- Physical or psychological limitations preventing participation in the TCM Daoyin intervention.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Qigong Research Institute
Shanghai, 200030
Ying Lu, Master, luwing_happy@163.com
Yanyan Shang, Master, shqgywk@163.com
About this study
Official title: TCM Daoyin for Anxiety and Depression Symptoms: Psychological Effects and Biological Mechanisms
This 12-week single-arm clinical trial investigates the effects of Traditional Chinese Medicine (TCM) Daoyin exercise on anxiety and depression symptoms in 20 participants, followed by a 12-week observational follow-up period.
The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores at 12 weeks. A secondary outcome will assess these scores at 24 weeks to evaluate sustained effects. Additional secondary outcomes include the Depression, Anxiety, and Stress Scale (DASS-21) and Pittsburgh Sleep Quality Index (PSQI) to further assess changes in mood and sleep quality at the same time points.
Exploratory analyses will examine inflammatory markers, immune cell subsets, serum metabolomics, and gut microbiota at baseline, 12 weeks, and 24 weeks to identify potential biological correlates. During the follow-up period, participants will record their actual exercise engagement, allowing investigators to explore long-term associations. Findings may provide insights for future mechanistic studies on TCM's role in mental health.
Read the detailed description
Anxiety and depression are among the most prevalent mental health conditions and are commonly associated with inflammation, immune dysregulation, and metabolic disturbances. Traditional Chinese Medicine (TCM) interventions, such as Daoyin exercise-a form of guided movement and breathing-have historically been used to promote mental well-being. However, their biological mechanisms remain inadequately understood.
This 12-week, single-arm clinical trial aims to evaluate the effects of a structured Daoyin exercise program on subclinical anxiety and depression symptoms in 20 adult participants. After completing the 12-week intervention, participants will enter a 12-week observational follow-up period, during which they may choose to continue or discontinue the practice at their discretion. Actual exercise engagement during the follow-up will be self-recorded using daily logs.
The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores from baseline to 12 weeks. A secondary outcome will assess the persistence of these effects at 24 weeks. Additional psychological assessments include the Depression, Anxiety, and Stress Scale (DASS-21) and the Pittsburgh Sleep Quality Index (PSQI), evaluated at baseline, 12 weeks, and 24 weeks to assess broader changes in mood and sleep quality.
Exploratory outcomes will investigate potential biological mechanisms by measuring:
- Inflammatory markers (e.g., interleukin-10 [IL-10], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]) via serum ELISA
- Immune cell subsets (e.g., cluster of differentiation 3-positive [CD3+], cluster of differentiation 4-positive [CD4+], cluster of differentiation 8-positive [CD8+] T cells) via flow cytometry
- Serum metabolomics using liquid chromatography-mass spectrometry (LC-MS) to identify metabolic changes potentially related to the effects of Daoyin exercise on anxiety and depression
- Gut microbiota composition using high-throughput sequencing techniques
Samples will be collected at baseline, 12 weeks, and 24 weeks. These data will help identify physiological pathways potentially linked to improvements in anxiety and depression symptoms.
Participants will be included based on clinician assessment and confirmed subclinical symptoms, with HAMA-14 scores between 14-29 and HAMD-17 scores between 7-14, without meeting ICD-10 diagnostic criteria for anxiety or depressive disorders. All psychological and biological evaluations will occur at three time points: baseline, post-intervention (12 weeks), and follow-up (24 weeks).
The results may offer preliminary evidence for integrating Daoyin exercise into mental health self-management strategies and provide a foundation for future research into TCM's biological mechanisms.
- Conditions
- Anxiety Symptom, Depression Symptom
- Being tested
- TCM Daoyin exercise
- Keywords
- Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM Daoyin exerciseBehavioural
Participants will receive a 12-week, group-based TCM Daoyin intervention consisting of two 90-minute sessions per week (total: 24 sessions), led by qualified physicians. Each session integrates movement regulation, breath regulation, and mind regulation, aiming to alleviate anxiety and depression symptoms. Each session includes a 10-minute warm-up and a 10-minute cool-down.
Compliance and Analysis:
Per-protocol analysis will include participants who attend ≥80% of sessions (≥19/24 sessions). Safety analyses will be conducted on all enrolled participants (n=20) following the intention-to-treat (ITT) principle.
| Study group | Role | What they receive |
|---|---|---|
| TCM Daoyin Exercise Group | Experimental | Participants will receive a 12-week TCM Daoyin training program led by qualified physicians. Structured group sessions will incorporate movement regulation, breath regulation, and mind regulation to alleviate anxiety and depression symptoms. Receives: Behavioral: TCM Daoyin exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety.
Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows:
- ≥29: Severe anxiety disorder
- 21-28: Marked anxiety disorder
- 14-20: Anxiety disorder
- 8-13: Suspected anxiety disorder
- ≤7: No anxiety disorder
Measured: Change from Baseline at 12 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression.
Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows:
- ≥25: Severe depression disorder
- 18-24: Moderate depression
- 13-17: Mild depression disorder
- 8-12: Suspected depression disorder
- ≤7: No depression disorder
Measured: Change from Baseline at 12 weeks
Secondary outcomes (10)
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety.
Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows:
- ≥29: Severe anxiety disorder
- 21-28: Marked anxiety disorder
- 14-20: Anxiety disorder
- 8-13: Suspected anxiety disorder
- ≤7: No anxiety disorder
Measured: Change from 12 weeks to 24 weeks
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety.
Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows:
- ≥29: Severe anxiety disorder
- 21-28: Marked anxiety disorder
- 14-20: Anxiety disorder
- 8-13: Suspected anxiety disorder
- ≤7: No anxiety disorder
Measured: Change from Baseline to 24 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression.
Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows:
- ≥25: Severe depression disorder
- 18-24: Moderate depression
- 13-17: Mild depression disorder
- 8-12: Suspected depression disorder
- ≤7: No depression disorder
Measured: Change from 12 weeks to 24 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression.
Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows:
- ≥25: Severe depression disorder
- 18-24: Moderate depression
- 13-17: Mild depression disorder
- 8-12: Suspected depression disorder
- ≤7: No depression disorder
Measured: Change from Baseline to 24 weeks
The Depression, Anxiety, and Stress Scale-21 (DASS-21)
The DASS-21 is a self-reported assessment used to measure the severity of depression, anxiety, and stress symptoms experienced by individuals over the past week. Higher cumulative scores on each subscale indicate more severe symptoms of depression, anxiety, or stress. The DASS-21 includes three subscales, each with 7 items: one for depression, one for anxiety, and one for stress. Each item is rated on a 4-point scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time).
Subscale scores are calculated by summing the responses to the seven items in each subscale and multiplying the total by 2. The following cutoff values are used to categorize symptom severity:
- Depression: A score greater than 9 indicates mild to severe depression.
- Anxiety: A score greater than 7 indicates mild to severe anxiety.
- Stress: A score greater than 14 indicates mild to severe stress.
Measured: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI consists of 19 self-rated items and 5 items rated by a roommate or bed partner. The 19th self-rated item and the 5 items rated by others are not included in the scoring. The remaining 18 self-rated items are grouped into 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating worse sleep quality. The total score is the sum of the 7 components, with a range of 0 to 21. It is used to assess the participant's subjective sleep quality over the past month, where higher scores indicate poorer sleep quality.
Measured: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
Changes in Inflammatory Markers
Changes in inflammatory markers (e.g., interleukin-10 [IL-10], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]) from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Measured: Change from Baseline at 12 weeks and 24 weeks
Changes in Immune Cell Subsets
Changes in immune cell subsets (e.g., cluster of differentiation 3-positive [CD3+], cluster of differentiation 4-positive [CD4+], cluster of differentiation 8-positive [CD8+] T cells) from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Measured: Change from Baseline at 12 weeks and 24 weeks
Changes in Serum Metabolomics
Changes in serum metabolomics from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Measured: Change from Baseline at 12 weeks and 24 weeks
Changes in Gut Microbiota
Changes in gut microbiota from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Measured: Change from Baseline at 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start10 Apr 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SymptomStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm trial with 20 participants undergoing a 12-week TCM Daoyin exercise intervention (2 sessions per week), followed by a 12-week observational follow-up period. Primary outcomes (HAMA-14 and HAMD-17 scores) and exploratory biomarkers (inflammatory markers, immune cell subsets, and serum metabolomics) will be assessed at baseline, 12 weeks, and 24 weeks. No control group is included.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Principal investigator, Lu Ying, MM, Shanghai University of Traditional Chinese Medicine
- Investigators
- Ying Lu, Master, Principal investigator, Shanghai Qigong Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921512
- Sponsor's protocol ID
- 24KFL060
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 29 Apr 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCM Daoyin for Anxiety and Depression Symptoms: Psychological Effects and Biological Mechanisms
- ClinicalTrials.gov ID
- NCT06921512
- Acronym / sponsor ID
- 24KFL060
- Conditions
- Anxiety Symptom, Depression Symptom
- Keywords
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
This 12-week single-arm clinical trial investigates the effects of Traditional Chinese Medicine (TCM) Daoyin exercise on anxiety and depression symptoms in 20 participants, followed by a 12-week observational follow-up period.
The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores at 12 weeks. A secondary outcome will assess these scores at 24 weeks to evaluate sustained effects. Additional secondary outcomes include the Depression, Anxiety, and Stress Scale (DASS-21) and Pittsburgh Sleep Quality Index (PSQI) to further assess changes in mood and sleep quality at the same time points.
Exploratory analyses will examine inflammatory markers, immune cell subsets, serum metabolomics, and gut microbiota at baseline, 12 weeks, and 24 weeks to identify potential biological correlates. During the follow-up period, participants will record their actual exercise engagement, allowing investigators to explore long-term associations. Findings may provide insights for future mechanistic studies on TCM's role in mental health.
Detailed description
Anxiety and depression are among the most prevalent mental health conditions and are commonly associated with inflammation, immune dysregulation, and metabolic disturbances. Traditional Chinese Medicine (TCM) interventions, such as Daoyin exercise-a form of guided movement and breathing-have historically been used to promote mental well-being. However, their biological mechanisms remain inadequately understood.
This 12-week, single-arm clinical trial aims to evaluate the effects of a structured Daoyin exercise program on subclinical anxiety and depression symptoms in 20 adult participants. After completing the 12-week intervention, participants will enter a 12-week observational follow-up period, during which they may choose to continue or discontinue the practice at their discretion. Actual exercise engagement during the follow-up will be self-recorded using daily logs.
The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores from baseline to 12 weeks. A secondary outcome will assess the persistence of these effects at 24 weeks. Additional psychological assessments include the Depression, Anxiety, and Stress Scale (DASS-21) and the Pittsburgh Sleep Quality Index (PSQI), evaluated at baseline, 12 weeks, and 24 weeks to assess broader changes in mood and sleep quality.
Exploratory outcomes will investigate potential biological mechanisms by measuring:
- Inflammatory markers (e.g., interleukin-10 [IL-10], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]) via serum ELISA
- Immune cell subsets (e.g., cluster of differentiation 3-positive [CD3+], cluster of differentiation 4-positive [CD4+], cluster of differentiation 8-positive [CD8+] T cells) via flow cytometry
- Serum metabolomics using liquid chromatography-mass spectrometry (LC-MS) to identify metabolic changes potentially related to the effects of Daoyin exercise on anxiety and depression
- Gut microbiota composition using high-throughput sequencing techniques
Samples will be collected at baseline, 12 weeks, and 24 weeks. These data will help identify physiological pathways potentially linked to improvements in anxiety and depression symptoms.
Participants will be included based on clinician assessment and confirmed subclinical symptoms, with HAMA-14 scores between 14-29 and HAMD-17 scores between 7-14, without meeting ICD-10 diagnostic criteria for anxiety or depressive disorders. All psychological and biological evaluations will occur at three time points: baseline, post-intervention (12 weeks), and follow-up (24 weeks).
The results may offer preliminary evidence for integrating Daoyin exercise into mental health self-management strategies and provide a foundation for future research into TCM's biological mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm trial with 20 participants undergoing a 12-week TCM Daoyin exercise intervention (2 sessions per week), followed by a 12-week observational follow-up period. Primary outcomes (HAMA-14 and HAMD-17 scores) and exploratory biomarkers (inflammatory markers, immune cell subsets, and serum metabolomics) will be assessed at baseline, 12 weeks, and 24 weeks. No control group is included.
| Arm | Type | Receives |
|---|---|---|
| TCM Daoyin Exercise Group | Experimental | Behavioral: TCM Daoyin exerciseParticipants will receive a 12-week TCM Daoyin training program led by qualified physicians. Structured group sessions will incorporate movement regulation, breath regulation, and mind regulation to alleviate anxiety and depression symptoms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary symptoms of anxiety and depression, with a Hamilton Anxiety Rating Scale (HAMA-14) score between 14 and 29 and a Hamilton Depression Rating Scale (HAMD-17) score between 7 and 14.
- No prior use of psychotropic medication, or at least six months since discontinuation.
- Aged 18 to 65 years (male or female).
- Clear consciousness and normal cognitive function, with the ability to communicate effectively, read, express thoughts, and engage in daily activities independently.
- Willing and able to comply with blood and stool sample collection.
Key exclusion criteria (6 listed)
- Diagnosed anxiety disorder or depressive disorder based on ICD-10 criteria.
- Bipolar disorder, psychotic disorders (e.g., schizophrenia), or organic mental disorders (e.g., Alzheimer's disease).
- History of alcohol or substance use disorder within the past year, current psychiatric medication use, or high suicide risk.
- Severe or unstable medical conditions, including immune or endocrine disorders or other serious illnesses.
- Physical or psychological limitations preventing participation in the TCM Daoyin intervention.
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 |
|---|---|---|
| TCM Daoyin exerciseParticipants will receive a 12-week, group-based TCM Daoyin intervention consisting of two 90-minute sessions per week (total: 24 sessions), led by qualified physicians. Each session integrates movement regulation, breath regulation, and mind regulation, aiming to alleviate anxiety and depression symptoms. Each session includes a 10-minute warm-up and a 10-minute cool-down. Compliance and Analysis: Per-protocol analysis will include participants who attend ≥80% of sessions (≥19/24 sessions). Safety analyses will be conducted on all enrolled participants (n=20) following the intention-to-treat (ITT) principle. | Behavioural | TCM Daoyin Exercise Group |
Primary outcome
14-item Hamilton Anxiety Rating Scale (HAMA-14)
Time frame: Change from Baseline at 12 weeks
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows: * ≥29: Severe anxiety disorder * 21-28: Marked anxiety disorder * 14-20: Anxiety disorder * 8-13: Suspected anxiety disorder * ≤7: No anxiety disorder
17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Change from Baseline at 12 weeks
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows: * ≥25: Severe depression disorder * 18-24: Moderate depression * 13-17: Mild depression disorder * 8-12: Suspected depression disorder * ≤7: No depression disorder
10 secondary outcomes
14-item Hamilton Anxiety Rating Scale (HAMA-14)
Time frame: Change from 12 weeks to 24 weeks
14-item Hamilton Anxiety Rating Scale (HAMA-14)
Time frame: Change from Baseline to 24 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Change from 12 weeks to 24 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Change from Baseline to 24 weeks
The Depression, Anxiety, and Stress Scale-21 (DASS-21)
Time frame: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
Changes in Inflammatory Markers
Time frame: Change from Baseline at 12 weeks and 24 weeks
Changes in Immune Cell Subsets
Time frame: Change from Baseline at 12 weeks and 24 weeks
Changes in Serum Metabolomics
Time frame: Change from Baseline at 12 weeks and 24 weeks
Changes in Gut Microbiota
Time frame: Change from Baseline at 12 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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.
Ying Lu, Master principal investigator
Shanghai Qigong Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM Daoyin exercise in people with Anxiety Symptom and Depression Symptom, run by Shanghai University of Traditional Chinese Medicine at 1 site 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Lu, Master (021-64394141, luyingtcm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-item Hamilton Anxiety Rating Scale (HAMA-14) (time frame: Change from Baseline at 12 weeks). 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 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.