Functional DyspepsiaNCT06466044
Effect and Mechanism of Auricular Acupressure on Functional Dyspepsia With Insomnia
A study testing Auricular acupressure in concha area and Auricular acupressure in earlobe in people with Functional Dyspepsia and Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region, and after clinical examination, including upper gastrointestinal endoscopy, the organic diseases causing the above symptoms are excluded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia, Insomnia
- What is being tested?
- Auricular acupressure in concha area and Auricular acupressure in earlobe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 20 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- It meets the diagnostic criteria of functional dyspepsia and insomnia
- Age 18 years or older
- The following drugs were not taken for at least 2 weeks before enrollment: antibiotics (oral, intramuscical and intravenous), microecological preparations (probiotics, prebiotics and Biostime, etc.) and other drugs affecting the gastrointestinal flora, any drugs or health products that improve sleep quality or inhibit neural activity in the brain, drugs related to the treatment of functional dyspepsia or other related treatments
- Agree to participate in the study voluntarily and sign the informed consent
Who cannot join
- Secondary insomnia caused by medication or other diseases;
- Patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems;
- Those who have previously received this treatment method or participated in other clinical trials within 6 months;
- Presence of contraindications for auricular patches, such as skin hypersensitivity or damage to the application site;
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
About this study
Official title: Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial
Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region, and after clinical examination, including upper gastrointestinal endoscopy, the organic diseases causing the above symptoms are excluded. According to Rome IV standard, functional dyspepsia can be divided into two categories: postprandial discomfort syndrome and epigastric pain syndrome. FD not only seriously affects the quality of life of patients, but also causes a heavy social and economic burden. Therefore, active prevention and treatment of FD, especially PDS, has become an unavoidable problem in clinic.
Epidemiological investigation shows that about 30% FD patients have many negative emotions such as insomnia, anxiety and depression, and many anti-negative emotional drugs themselves can cause gastrointestinal side effects, which are considered to be the key reasons for the recurrence of symptoms. In recent years, people have paid more and more attention to the brain-gut axis. Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators. In addition, the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine. However, the relationship between specific bile acids, microflora and functional dyspepsia is still uncertain.
At present, the effective and safe treatment methods for FD with insomnia are still very limited. In recent years, Auricular Acupressure has obvious advantages in treating FD with insomnia. This study plans to study the clinical efficacy and mechanism of Auricular Acupressure on functional dyspepsia with insomnia. Provide more treatment methods and ideas for clinicians, popularize and apply green diagnosis and treatment methods, bring good news to more patients, and produce remarkable economic and social benefits
Read the detailed description
- The effective rate. The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline
- PSQI score. The PSQI is a widely used questionnaire to assess one's sleep quality for the past month, with 7 components for 7 specific features of sleep.
- sleep quality assessed by actigraphy: Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT.
- modified FDSD
- SF-NDI: Evaluate the functional dyspepsia of patients with functional dyspepsia and insomnia by SF-NDI.
- SAS, SDS: SAS and SDS were used to evaluate the patients' psychological status.
- HAS, HRV: Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability.
- To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics.
- The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
- Averse events. Any adverse events, such as unfavorable or unintended signs, symptoms, or diseases, related to the AA treatment or the administration of these comorbidity was reported by patients and professional nurses. Severe adverse events had to be reported to the principal investigator and the data and safety monitoring board within 24 hours after their occurrence.
- Conditions
- Functional Dyspepsia, Insomnia
- Being tested
- Auricular acupressure in concha area, Auricular acupressure in earlobe
- Keywords
- Auricular Acupressure, Functional Dyspepsia, insomnia, clinical efficacy, Effect mechanism study
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressure in concha areaBehavioural
The method of pressing beans on auricular points is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, relevant auricular points are selected, and appropriate stimulation such as kneading, pressing, pinching and pressing is given to the seeds of Vaccaria seed attached to the concha auricularis, so that the auricular points can produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.
Auricular acupressure in earlobeBehavioural
The auricular point pressing bean method is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, the relevant auricular points are selected, and the seeds attached to the ear lobe, which is the least innervated part of vagus nerve, are given appropriate stimulation such as kneading, pressing, pinching and pressing, so that the auricular points produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Auricular point containing Vaccaria seed was attached to the auricular concha area rich in vagus nerve. Frequency: Press the auricular points three times a day within half an hour after meals, and press the auricular points for about 30 times. Press the auricular concha alternately. The treatment lasted for 2 weeks. Go to the hospital once a week to change the ear patch. Receives: Behavioral: Auricular acupressure in concha area |
| Control group | Sham comparator | Auricular point with Vaccaria seed was attached to the earlobe, which is the place with the least vagal innervation. Frequency: Press the auricular points three times a day within half an hour after meals, and press the auricular points for about 30 times. Press the bilateral earlobes alternately. The treatment lasted for 2 weeks. Go to the hospital to change the ear patch once a week. Receives: Behavioral: Auricular acupressure in earlobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effective rate at week 2
The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline PSQI score
Measured: 2-week
Secondary outcomes (13)
the effective rate at week 8
The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 8 weeks as compared with the baseline PSQI score
Measured: 8-week after treatment
short form-Nepean dyspepsia Index
Clinical functional dyspepsia was assessed by the short form-Nepean dyspepsia Index scale. The short form-Nepean dyspepsia Index scale is scored using a 5-point Likert scale (1-5 points), with the lowest score of 10 points and the highest score of 50 points.
Measured: baseline, 2 weeks, 8 weeks after treatment
Pittsburgh Sleep Quality Index
Clinical sleep was assessed by the Pittsburgh Sleep Quality Index. This scale is scored on a scale of 0-3, with a cumulative score of PQSI total score (0-21) and a maximum score of 21. The higher the score, the worse the quality of sleep.
Measured: baseline, 2 weeks, 8 weeks after treatment
Self-rated Anxiety Scale
Clinical sleep was assessed by the Self-rated Anxiety Scal.The anxiety self-rating scale is scored on a 4-point scale, with a maximum score of 100 and a minimum score of 20. The higher the score, the more severe the anxiety symptoms. A score below 50 is normal; 50-60 is mild; A score of 70 or more is considered severe.
Measured: baseline, 2 weeks, 8 weeks after treatment
Self-rated Depression Scale
Clinical sleep was assessed by the Self-rated Depression Scale. The depression self-rating scale is scored on a 4-point scale, with a maximum score of 100 and a minimum score of 20. The higher the score, the more severe the depressive symptoms. A score of 53-62 is mild depression, 63-72 is moderate depression, and a score above 72 is severe depression.
Measured: baseline, 2 weeks, 8 weeks after treatment
Hyperarousal scale
Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale
Measured: baseline, 2 weeks, 8 weeks after treatment
Heart rate variability
Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale
Measured: baseline, 2 weeks, 8 weeks after treatment
Sleep efficiency
We will collect the sleep efficiency of patients before and after treatment by ActiGraph wGT3X-BT. >85% indicates good sleep quality. 85% or less indicates poor sleep quality.
Measured: baseline, 2 weeks, 8 weeks after treatment
Total sleep time.
We will collect the total sleep time of patients before and after treatment by ActiGraph wGT3X-BT. An increase in total sleep time indicates improved sleep quality.
Measured: baseline, 2 weeks, 8 weeks after treatment
Wake After Sleep Onset
We will collect the post-sleep awakening time of patients before and after treatment by ActiGraph wGT3X-BT. Increased waking after sleep onset suggests poorer sleep quality.
Measured: baseline, 2 weeks, 8 weeks after treatment
Sleep fragmentation index
We will collect the sleep fragmentation index of patients before and after treatment by ActiGraph wGT3X-BT. An increase in the sleep fragmentation index indicates poor sleep quality.
Measured: baseline, 2 weeks, 8 weeks after treatment
OTE
To assess patient satisfaction with treatment of functional dyspepsia
Measured: baseline, 2 weeks, 8 weeks after treatment
modified FDSD,
The patient was evaluated for symptoms of functional dyspepsia
Measured: baseline, 2 weeks, 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 May 2024
- Primary completion31 Dec 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies 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 two groups affixed the auricular points with Vaccaria seed to the ear, the control group affixed to the ear lobe, and the experimental group affixed to the ear nail area. The ear compression treatment was performed, and the pressure was subject to the patient's gas state (acid, numbness, weight, swelling, etc.). Frequency: 3 times a day, press the ear point within half an hour after a meal, the press frequency is about 30 times, and the bilateral ear lobe is alternately pressed. The treatment lasted for 2 weeks. Go to the hospital once a week to change the ear patch.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu JianNong, doctor, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466044
- Sponsor's protocol ID
- 2024-KLS-231-05
- Status last verified
- Jun 2025
- First submitted
- 14 May 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen MY, Li ZJ, Zhou R, Lou QY, Ying ZK, Liu S, Feng DD, Yang DD, Jiang LX, Wang XL, Wu JX, Li M, Wu JN. Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Dec 10. doi: 10.14309/ajg.0000000000003880. Online ahead of print.
PubMed 41369283Shen MY, Lou QY, Liu S, Li ZJ, Lin TC, Zhou R, Feng DD, Yang DD, Wu JN. The efficacy and safety of auricular acupoint therapy on treating functional dyspepsia with insomnia: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Mar 12;12:1496502. doi: 10.3389/fmed.2025.1496502. eCollection 2025.
PubMed 40144883
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06466044
- Acronym / sponsor ID
- 2024-KLS-231-05
- Conditions
- Functional Dyspepsia, Insomnia
- Keywords
- Auricular Acupressure, Functional Dyspepsia, insomnia, clinical efficacy, Effect mechanism study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 20 Jun 2024 (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.
Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region, and after clinical examination, including upper gastrointestinal endoscopy, the organic diseases causing the above symptoms are excluded. According to Rome IV standard, functional dyspepsia can be divided into two categories: postprandial discomfort syndrome and epigastric pain syndrome. FD not only seriously affects the quality of life of patients, but also causes a heavy social and economic burden. Therefore, active prevention and treatment of FD, especially PDS, has become an unavoidable problem in clinic.
Epidemiological investigation shows that about 30% FD patients have many negative emotions such as insomnia, anxiety and depression, and many anti-negative emotional drugs themselves can cause gastrointestinal side effects, which are considered to be the key reasons for the recurrence of symptoms. In recent years, people have paid more and more attention to the brain-gut axis. Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators. In addition, the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine. However, the relationship between specific bile acids, microflora and functional dyspepsia is still uncertain.
At present, the effective and safe treatment methods for FD with insomnia are still very limited. In recent years, Auricular Acupressure has obvious advantages in treating FD with insomnia. This study plans to study the clinical efficacy and mechanism of Auricular Acupressure on functional dyspepsia with insomnia. Provide more treatment methods and ideas for clinicians, popularize and apply green diagnosis and treatment methods, bring good news to more patients, and produce remarkable economic and social benefits
Detailed description
- The effective rate. The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline
- PSQI score. The PSQI is a widely used questionnaire to assess one's sleep quality for the past month, with 7 components for 7 specific features of sleep.
- sleep quality assessed by actigraphy: Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT.
- modified FDSD
- SF-NDI: Evaluate the functional dyspepsia of patients with functional dyspepsia and insomnia by SF-NDI.
- SAS, SDS: SAS and SDS were used to evaluate the patients' psychological status.
- HAS, HRV: Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability.
- To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics.
- The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
- Averse events. Any adverse events, such as unfavorable or unintended signs, symptoms, or diseases, related to the AA treatment or the administration of these comorbidity was reported by patients and professional nurses. Severe adverse events had to be reported to the principal investigator and the data and safety monitoring board within 24 hours after their occurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the two groups affixed the auricular points with Vaccaria seed to the ear, the control group affixed to the ear lobe, and the experimental group affixed to the ear nail area. The ear compression treatment was performed, and the pressure was subject to the patient's gas state (acid, numbness, weight, swelling, etc.). Frequency: 3 times a day, press the ear point within half an hour after a meal, the press frequency is about 30 times, and the bilateral ear lobe is alternately pressed. The treatment lasted for 2 weeks. Go to the hospital once a week to change the ear patch.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Auricular acupressure in concha areaAuricular point containing Vaccaria seed was attached to the auricular concha area rich in vagus nerve. Frequency: Press the auricular points three times a day within half an hour after meals, and press the auricular points for about 30 times. Press the auricular concha alternately. The treatment lasted for 2 weeks. Go to the hospital once a week to change the ear patch. |
| Control group | Sham comparator | Behavioral: Auricular acupressure in earlobeAuricular point with Vaccaria seed was attached to the earlobe, which is the place with the least vagal innervation. Frequency: Press the auricular points three times a day within half an hour after meals, and press the auricular points for about 30 times. Press the bilateral earlobes alternately. The treatment lasted for 2 weeks. Go to the hospital to change the ear patch once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- It meets the diagnostic criteria of functional dyspepsia and insomnia
- Age 18 years or older
- The following drugs were not taken for at least 2 weeks before enrollment: antibiotics (oral, intramuscical and intravenous), microecological preparations (probiotics, prebiotics and Biostime, etc.) and other drugs affecting the gastrointestinal flora, any drugs or health products that improve sleep quality or inhibit neural activity in the brain, drugs related to the treatment of functional dyspepsia or other related treatments
- Agree to participate in the study voluntarily and sign the informed consent
Key exclusion criteria (5 listed)
- Secondary insomnia caused by medication or other diseases;
- Patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems;
- Those who have previously received this treatment method or participated in other clinical trials within 6 months;
- Presence of contraindications for auricular patches, such as skin hypersensitivity or damage to the application site;
- Pregnant and lactating women.
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 |
|---|---|---|
| Auricular acupressure in concha areaThe method of pressing beans on auricular points is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, relevant auricular points are selected, and appropriate stimulation such as kneading, pressing, pinching and pressing is given to the seeds of Vaccaria seed attached to the concha auricularis, so that the auricular points can produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes. | Behavioural | Treatment group |
| Auricular acupressure in earlobeThe auricular point pressing bean method is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, the relevant auricular points are selected, and the seeds attached to the ear lobe, which is the least innervated part of vagus nerve, are given appropriate stimulation such as kneading, pressing, pinching and pressing, so that the auricular points produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes. | Behavioural | Control group |
Primary outcome
the effective rate at week 2
Time frame: 2-week
The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline PSQI score
13 secondary outcomes
the effective rate at week 8
Time frame: 8-week after treatment
short form-Nepean dyspepsia Index
Time frame: baseline, 2 weeks, 8 weeks after treatment
Pittsburgh Sleep Quality Index
Time frame: baseline, 2 weeks, 8 weeks after treatment
Self-rated Anxiety Scale
Time frame: baseline, 2 weeks, 8 weeks after treatment
Self-rated Depression Scale
Time frame: baseline, 2 weeks, 8 weeks after treatment
Hyperarousal scale
Time frame: baseline, 2 weeks, 8 weeks after treatment
Heart rate variability
Time frame: baseline, 2 weeks, 8 weeks after treatment
Sleep efficiency
Time frame: baseline, 2 weeks, 8 weeks after treatment
Total sleep time.
Time frame: baseline, 2 weeks, 8 weeks after treatment
Wake After Sleep Onset
Time frame: baseline, 2 weeks, 8 weeks after treatment
Sleep fragmentation index
Time frame: baseline, 2 weeks, 8 weeks after treatment
OTE
Time frame: baseline, 2 weeks, 8 weeks after treatment
modified FDSD,
Time frame: baseline, 2 weeks, 8 weeks after treatment
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 1 Jul 2025.
- Derived from this study: PubMed 41369283Shen MY, Li ZJ, Zhou R, Lou QY, Ying ZK, Liu S, Feng DD, Yang DD, Jiang LX, Wang XL, Wu JX, Li M, Wu JN. Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Dec 10. doi: 10.14309/ajg.0000000000003880. Online ahead of print.
- Derived from this study: PubMed 40144883Shen MY, Lou QY, Liu S, Li ZJ, Lin TC, Zhou R, Feng DD, Yang DD, Wu JN. The efficacy and safety of auricular acupoint therapy on treating functional dyspepsia with insomnia: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Mar 12;12:1496502. doi: 10.3389/fmed.2025.1496502. eCollection 2025.
- 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.
Wu JianNong, doctor principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure in concha area and Auricular acupressure in earlobe in people with Functional Dyspepsia and Insomnia, run by The First Affiliated Hospital of Zhejiang Chinese Medical University 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 4 inclusion and 5 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 1 Jul 2025. 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. 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?
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?
the effective rate at week 2 (time frame: 2-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466044, which also lists 2 linked publications.
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 1 Jul 2025.