AcupunctureNCT05923021
Moderate Depressive Disorder With Cheek Acupuncture
A study testing cheek acupuncture in people with Acupuncture and Depression, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial summary
This study intends to use a randomized controlled clinical study to clarify the clinical efficacy of cheek acupuncture therapy in patients with moderate depressive disorder. And also to find the antidepressant mechanism of cheek acupuncture therapy on moderate depressive disorder by using resting state functional… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Acupuncture, Depression
- What is being tested?
- cheek acupuncture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Dec 2024
- Phase
- Interventional
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ① Conforming to the diagnostic standards of traditional Chinese and Western medicine;
- Age range from 10 to 65 years old;
- HAMD-17 scores>14 ;
- Sign an informed consent form (Minors need to obtain recognition from their guardians and have their informed consent signed by their guardians) and voluntarily participate in this study.
- Only those who meet the above 4 criteria can be included in the study.
Who cannot join
- ①Individuals with significant suicidal tendencies;
- Previously diagnosed with intellectual disabilities, schizophrenia, bipolar disorder, substance abuse (such as alcohol dependence), or other mental disorders;
- Epilepsy history or strong positive epilepsy family history, brain organic disease and serious physical disease history;
- Individuals who are taking antidepressants within 6 weeks (including 6 weeks);
- Pregnancy, preparation or lactation period;
- Patients with skin lesions or skin diseases, severe diabetes, tumors and dysfunction of important organs, or severe internal diseases such as liver, kidney, cardiovascular, endocrine, respiratory and hematopoietic systems;
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- ⑦ Contraindications for fMRI examination, such as pacemakers, cardiac stents, and claustrophobia;
- Patients with other central or peripheral neuropathy.
- Those who meet any of the above criteria will be excluded from the study
About this study
Official title: A Randomized Controlled Study on the Treatment of Moderate Depressive Disorder With Cheek Acupuncture
This study intends to use a randomized controlled clinical study to clarify the clinical efficacy of cheek acupuncture therapy in patients with moderate depressive disorder. And also to find the antidepressant mechanism of cheek acupuncture therapy on moderate depressive disorder by using resting state functional magnetic resonance imaging. The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep quality of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
Read the detailed description
Cheek acupuncture therapy refers to a new painless acupuncture therapy for treating systemic diseases by acupuncture at specific points on the cheek. This therapy was founded by Professor Wang Yongzhou, a scholar in France. Cheek acupuncture therapy takes the Yellow Emperor's Internal Classic as the theoretical basis, and organically integrates holographic theory, the theory of ascending and descending qi, the theory of Big Three Jiao, the theory of simultaneous treatment of mind and body, and the theory of the book of Changes. After long-term and extensive clinical practice and continuous experience summary, a relatively independent and complete treatment system has been formed. Since its initial discovery in 1991, cheek acupuncture has undergone clinical observation and verification by numerous doctors for nearly 100000 times. Its therapeutic effect is stable and reliable, and it has a strong therapeutic advantage for psychosomatic diseases represented by depression. The members of the research group have been learning about cheek acupuncture since 2017 and have applied it to the treatment of patients with depression, achieving satisfactory clinical efficacy.
Major depressive disorder (MDD) is a type of disorder with high incidence, recurrence, disability, and the risk of suicide for severe mental disorders with a high suicide rate is about 20 times higher than that of the general population. The main clinical features of this disease are low mood, decreased interest, and lacking in strength. Many patients also experience symptoms such as cognitive decline, autonomic dysfunction, sleep disorders, and altered appetite. A 2013 study on the global burden of disease pointed out that depression is the second largest burden disease worldwide, with a prevalence rate of 6.7% in China About 9%, with a total number of approximately 95 million cases. Deeply exploring the pathogenesis of depression and exploring new antidepressant therapies have significant practical significance.
In this situation, the investigators design a randomized controlled clinical study, firstly to clarify the cure effect of cheek acupuncture therapy, secondly to find the central mechanism of it on antidepressant effect.The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
- Conditions
- Acupuncture, Depression
- Being tested
- cheek acupuncture
- Keywords
- cheek acupuncture, depression, MDD, RCT research, functional links
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cheek acupunctureOther
Also called Sertraline Hydrochloride Tablets
Cheek acupuncture therapy refers to a new painless acupuncture therapy for treating systemic diseases by acupuncture at specific points on the cheek. This therapy was founded by Professor Wang Yongzhou, a scholar in France. Cheek acupuncture therapy takes the Yellow Emperor's Internal Classic as the theoretical basis, and organically integrates holographic theory, the theory of ascending and descending qi, the theory of Big Three Jiao, the theory of simultaneous treatment of mind and body, and the theory of the book of Changes.In this study, we use the big three jiao points, head points, and neck points in cheek acupuncture therapy to treat depression. These acupoints are considered effective in long-term clinical applications.
| Study group | Role | What they receive |
|---|---|---|
| Cheek acupuncture treatment group | Experimental | Needle selection: Select disposable trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) .
Acupoints selection: bilateral Sanjiao points, bilateral head points, bilateral neck points, Needling depth: about 5mm-7.5mm, Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 cheek acupuncture treatments for 12 weeks. Receives: Other: cheek acupuncture |
| Sham cheek acupuncture treatment group | Sham comparator | Needle selection: Select disposable flat head trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) .
Acupoints selection: Translate the bilateral Sanjiao points forward by 1cm（towards the front midline of the body）, translate the bilateral head points forward by 1cm, bilateral back points, Needling depth: Retained on the surface of the skin with the help of a cannula， Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 times of cheek acupuncture treatments for 12 weeks. Receives: Other: cheek acupuncture |
| Drug group | Active comparator | Drug name: Sertraline Hydrochloride Tablets (trade name: Levofloxacin Sertraline, produced by Pfizer Pharmaceutical Co., Ltd., batch number: H10980141),
Dosage form: tablets
Usage: Take orally. 50 mg/d, taken after breakfast.
Depending on the patient's condition, the dosage can be increased to 200mg/d, taken after breakfast, or divided twice a day after meals
Treatment cycle: a total of 12 weeks. Receives: Other: cheek acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change HAMD-17 score is being assessed at different time points
The most commonly used scale for clinical assessment with depression. A score more than or equal to 24 indicates severe depression, a score more than or equal to 17 and less than 24 indicates moderate depression, and a score less than 7 indicates no depression.
Measured: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Secondary outcomes (2)
Change PSQI score is being assessed at different time points
It will be used to evaluate the sleep quality of subjects in the past month, the scale consists of 18 self-assessment items combined into 7 factors, each factor scored on a 0-3 scale, and the total score of each factor is the PSQI total score. The higher the score, the poorer the sleep quality. Generally, a score of 7 is the cutoff value, while a PSQI ≥ 8 indicates poor sleep quality.
Measured: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Change HAMA score is being assessed at different time points
It is an anxiety assessment scale with a total of 14 items, and each symptom is divided into 0-4 points. A score less than 7 indicates no anxiety, more than or equal to 7 indicates possible anxiety.
Measured: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923021
- Sponsor's protocol ID
- 2023-KLS-049-01
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Treatment of Moderate Depressive Disorder With Cheek Acupuncture
- ClinicalTrials.gov ID
- NCT05923021
- Acronym / sponsor ID
- 2023-KLS-049-01
- Conditions
- Acupuncture, Depression
- Keywords
- cheek acupuncture, depression, MDD, RCT research, functional links
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Jun 2023 (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 study intends to use a randomized controlled clinical study to clarify the clinical efficacy of cheek acupuncture therapy in patients with moderate depressive disorder. And also to find the antidepressant mechanism of cheek acupuncture therapy on moderate depressive disorder by using resting state functional magnetic resonance imaging. The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep quality of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
Detailed description
Cheek acupuncture therapy refers to a new painless acupuncture therapy for treating systemic diseases by acupuncture at specific points on the cheek. This therapy was founded by Professor Wang Yongzhou, a scholar in France. Cheek acupuncture therapy takes the Yellow Emperor's Internal Classic as the theoretical basis, and organically integrates holographic theory, the theory of ascending and descending qi, the theory of Big Three Jiao, the theory of simultaneous treatment of mind and body, and the theory of the book of Changes. After long-term and extensive clinical practice and continuous experience summary, a relatively independent and complete treatment system has been formed. Since its initial discovery in 1991, cheek acupuncture has undergone clinical observation and verification by numerous doctors for nearly 100000 times. Its therapeutic effect is stable and reliable, and it has a strong therapeutic advantage for psychosomatic diseases represented by depression. The members of the research group have been learning about cheek acupuncture since 2017 and have applied it to the treatment of patients with depression, achieving satisfactory clinical efficacy.
Major depressive disorder (MDD) is a type of disorder with high incidence, recurrence, disability, and the risk of suicide for severe mental disorders with a high suicide rate is about 20 times higher than that of the general population. The main clinical features of this disease are low mood, decreased interest, and lacking in strength. Many patients also experience symptoms such as cognitive decline, autonomic dysfunction, sleep disorders, and altered appetite. A 2013 study on the global burden of disease pointed out that depression is the second largest burden disease worldwide, with a prevalence rate of 6.7% in China About 9%, with a total number of approximately 95 million cases. Deeply exploring the pathogenesis of depression and exploring new antidepressant therapies have significant practical significance.
In this situation, the investigators design a randomized controlled clinical study, firstly to clarify the cure effect of cheek acupuncture therapy, secondly to find the central mechanism of it on antidepressant effect.The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
| Arm | Type | Receives |
|---|---|---|
| Cheek acupuncture treatment group | Experimental | Other: cheek acupunctureNeedle selection: Select disposable trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) . Acupoints selection: bilateral Sanjiao points, bilateral head points, bilateral neck points, Needling depth: about 5mm-7.5mm, Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 cheek acupuncture treatments for 12 weeks. |
| Sham cheek acupuncture treatment group | Sham comparator | Other: cheek acupunctureNeedle selection: Select disposable flat head trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) . Acupoints selection: Translate the bilateral Sanjiao points forward by 1cm（towards the front midline of the body）, translate the bilateral head points forward by 1cm, bilateral back points, Needling depth: Retained on the surface of the skin with the help of a cannula， Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 times of cheek acupuncture treatments for 12 weeks. |
| Drug group | Active comparator | Other: cheek acupunctureDrug name: Sertraline Hydrochloride Tablets (trade name: Levofloxacin Sertraline, produced by Pfizer Pharmaceutical Co., Ltd., batch number: H10980141), Dosage form: tablets Usage: Take orally. 50 mg/d, taken after breakfast. Depending on the patient's condition, the dosage can be increased to 200mg/d, taken after breakfast, or divided twice a day after meals Treatment cycle: a total of 12 weeks. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ① Conforming to the diagnostic standards of traditional Chinese and Western medicine;
- Only those who meet the above 4 criteria can be included in the study.
Key exclusion criteria (9 listed)
- ①Individuals with significant suicidal tendencies;
- ⑦ Contraindications for fMRI examination, such as pacemakers, cardiac stents, and claustrophobia;
- Those who meet any of the above criteria will be excluded from the study
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 |
|---|---|---|
| cheek acupunctureAlso: Sertraline Hydrochloride TabletsCheek acupuncture therapy refers to a new painless acupuncture therapy for treating systemic diseases by acupuncture at specific points on the cheek. This therapy was founded by Professor Wang Yongzhou, a scholar in France. Cheek acupuncture therapy takes the Yellow Emperor's Internal Classic as the theoretical basis, and organically integrates holographic theory, the theory of ascending and descending qi, the theory of Big Three Jiao, the theory of simultaneous treatment of mind and body, and the theory of the book of Changes.In this study, we use the big three jiao points, head points, and neck points in cheek acupuncture therapy to treat depression. These acupoints are considered effective in long-term clinical applications. | Other | Cheek acupuncture treatment group, Drug group, Sham cheek acupuncture treatment group |
Primary outcome
Change HAMD-17 score is being assessed at different time points
Time frame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
The most commonly used scale for clinical assessment with depression. A score more than or equal to 24 indicates severe depression, a score more than or equal to 17 and less than 24 indicates moderate depression, and a score less than 7 indicates no depression.
2 secondary outcomes
Change PSQI score is being assessed at different time points
Time frame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Change HAMA score is being assessed at different time points
Time frame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing cheek acupuncture in people with Acupuncture and Depression, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Change HAMD-17 score is being assessed at different time points (time frame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks). 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 28 Jun 2023.