Qi Stagnation ConstitutionNCT07508748
A Study on the Effects and Mechanisms of Non-invasive Acupoint Stimulation in Intervening in High Stress Sensitivity Among Young and Middle-aged Women With Qi Stagnation Constitution
A study testing Non-invasive Steam-warm Acupoint Stimulation and Non-invasive Pressure Acupoint Stimulation in people with Qi Stagnation Constitution and Acupoints, run by ChinaNorm at 1 site in China.
Trial summary
This is a randomized, placebo-controlled trial with a cross-over component. It investigates the effect of non-invasive acupoint stimulation on stress in young and middle-aged women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Qi Stagnation Constitution, Acupoints
- What is being tested?
- Non-invasive Steam-warm Acupoint Stimulation and Non-invasive Pressure Acupoint Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 30 Jul 2026
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 20-40 years.
- Regular daily routine with relatively fixed wake-up and bedtimes, sufficient sleep (7-9 hours), regular diet, moderate physical activity, and avoidance of shift work.
- Intact structure of major organ systems, with no active diseases or pathological damage.
- Regular menstrual cycle (21-35 days) and normal menstrual period (3-7 days).
- For the experimental group (Qi Yu constitution group):
- Perceived Stress Scale (PSS-14) score ≥ 43.
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- Qi Yu Constitution Subscale score ≥ 40.
- Diagnosis by a qualified TCM physician according to standard procedures, confirming characteristics of Qi Yu constitution, including (physical symptoms partially required):
- Body type: Tending to be thin.
- Psychological characteristics: Introverted, unstable, sensitive, suspicious, with significant emotional fluctuations.
- Somatic symptoms: Fullness or migrating pain in the chest and hypochondrium, frequent sighing; sensation of a foreign body in the throat (globus hystericus); sleep disturbances (difficulty falling asleep, early awakening). Poor appetite, frequent belching.
- Tongue and pulse: Pale red tongue with thin white coating, wiry and thin pulse.
- For the control group (non-Qi Yu constitution group):
- Perceived Stress Scale (PSS-14) score ≤ 42.
- Qi Yu Constitution Subscale score < 30.
- No relevant clinical manifestations upon TCM examination.
- Signed informed consent form, voluntarily participating in the trial.
- Willing to comply with all testing requirements.
- No infection or bleeding tendency on the skin of the five acupoint areas (GV20/Baihui, LI4/Hegu, LR3/Taichong, PC6/Neiguan, SP6/Sanyinjiao), not affecting the use of the study products.
Who cannot join
- Participation in any other clinical trial evaluation within the past 1 month.
- Presence of organic diseases, such as various malignant tumors, certain chronic diseases (heart disease, diabetes, anemia, etc.), certain gynecological diseases (uterine fibroids, endometriosis, severe mammary hyperplasia, etc.), or certain endocrine diseases (hyperthyroidism or hypothyroidism, etc.).
- Individuals with hypothalamic-pituitary-adrenal (HPA) axis dysfunction, such as those with endocrine diseases (e.g., hyper/hypothyroidism, Cushing's syndrome, congenital adrenal hyperplasia, primary chronic adrenocortical insufficiency).
- Individuals diagnosed with major depressive disorder or anxiety disorder, bipolar disorder, schizophrenia, etc.
- Use of antidepressants, anti-anxiety medications, glucocorticoids, or immunosuppressants within the past 4 weeks.
- Recent (within the past 3 months) suicidal ideation or self-harm behavior.
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- Receipt of acupuncture, massage, or other TCM treatments or psychological interventions (e.g., cognitive behavioral therapy) within the past 4 weeks.
- Suffering from autoimmune diseases requiring long-term use of hormones.
- Alcohol or drug dependence.
- Experienced major stressful life events (e.g., bereavement of a close relative suffering a major psychological blow) in the past year.
- Physically weak or unable to tolerate the arithmetic stress in the MIST task.
- Conditions such as epilepsy, hypertension, or heart disease that are unsuitable for undergoing induced psychological stress.
- Inability to cooperate in completing the MIST task (e.g., due to visual/auditory impairment, cognitive dysfunction).
- Inability or unwillingness to attend all study visits and comply with the treatment regimen.
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
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
Shanghai
About this study
This is a randomized, placebo-controlled trial with a cross-over component. It investigates the effect of non-invasive acupoint stimulation on stress in young and middle-aged women. A total of 90 participants will be enrolled: 60 with a Liver-Qi Stagnation constitution and high perceived stress, and 30 without this constitution as a non-intervention baseline control. The 60 participants with the target constitution will be randomized into two groups. One group (n=30) will undergo a cross-over intervention, sequentially receiving steam-warm acupressure and simple acupressure (at five acupoints) in a randomized order, separated by a washout period. The other group (n=30) will receive placebo stimulation. The primary outcome is the change in the Perceived Stress Scale (PSS-14) score. Secondary outcomes include physiological stress responses.
- Conditions
- Qi Stagnation Constitution, Acupoints
- Being tested
- Non-invasive Steam-warm Acupoint Stimulation, Non-invasive Pressure Acupoint Stimulation, Placebo Acupoint Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Steam-warm Acupoint StimulationOther
Participants will use a self-use device to apply steam-warm acupoint stimulation at five acupoints (GV20/Baihui, PC6/Neiguan, LI4/Hegu, SP6/Sanyinjiao, LR3/Taichong). The device consists of a main body (Part A) containing a heating element and high-hardness non-woven protrusions, secured by a adjustable strap (Part B). Stimulation is applied for 20 minutes per session, 3 times per week.
Non-invasive Pressure Acupoint StimulationOther
Participants will use a self-use device to apply pressure-only acupoint stimulation at the same five acupoints as above. The device is visually similar to the steam-warm device but Part A contains a non-heating, shaped hard sheet and high-hardness non-woven protrusions. It is secured by the same adjustable strap (Part B). Stimulation is applied for 20 minutes per session, 3 times per week.
Placebo Acupoint StimulationOther
Participants will use a self-use device designed to mimic the active intervention devices in appearance. The device's Part A contains a non-heating, shaped hard sheet and low-hardness non-woven protrusions that deliver minimal pressure, secured by the same adjustable strap (Part B). It is applied to the same five acupoints for 20 minutes per session, 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Steam-warm and Simple Acupressure Crossover Group | Other | Non-invasive acupoint stimulation Receives: Other: Non-invasive Steam-warm Acupoint Stimulation; Other: Non-invasive Pressure Acupoint Stimulation |
| Placebo Control | Other | Not described Receives: Other: Placebo Acupoint Stimulation |
| Healthy Baseline Control (No Intervention) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS-14) Score
Measured: From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4).
Secondary outcomes (3)
Change in Heart Rate Variability (HRV) Parameters during Acute Stress
Measured: During each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention (Week 11, for the crossover group).
Change in Psychophysiological Response to the Montreal Imaging Stress Task (MIST)
Measured: During each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention (Week 11, for the crossover group).
Change in Salivary Cortisol and 3-Methoxy-4-hydroxyphenylglycol (MHPG) Levels during Acute Stress
Measured: Saliva samples are collected at multiple timepoints (T0, T15, T20, T25, T30 minutes) during each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start7 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Qi Stagnation ConstitutionStudies of the same condition, open and under way.
- More trials run by ChinaNormThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508748
- Sponsor's protocol ID
- C25023004
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects and Mechanisms of Non-invasive Acupoint Stimulation in Intervening in High Stress Sensitivity Among Young and Middle-aged Women With Qi Stagnation Constitution
- ClinicalTrials.gov ID
- NCT07508748
- Acronym / sponsor ID
- C25023004
- Conditions
- Qi Stagnation Constitution, Acupoints
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Apr 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.
This is a randomized, placebo-controlled trial with a cross-over component. It investigates the effect of non-invasive acupoint stimulation on stress in young and middle-aged women. A total of 90 participants will be enrolled: 60 with a Liver-Qi Stagnation constitution and high perceived stress, and 30 without this constitution as a non-intervention baseline control. The 60 participants with the target constitution will be randomized into two groups. One group (n=30) will undergo a cross-over intervention, sequentially receiving steam-warm acupressure and simple acupressure (at five acupoints) in a randomized order, separated by a washout period. The other group (n=30) will receive placebo stimulation. The primary outcome is the change in the Perceived Stress Scale (PSS-14) score. Secondary outcomes include physiological stress responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Steam-warm and Simple Acupressure Crossover Group | Other | Other: Non-invasive Steam-warm Acupoint Stimulation, Other: Non-invasive Pressure Acupoint StimulationNon-invasive acupoint stimulation |
| Placebo Control | Other | Other: Placebo Acupoint Stimulation |
| Healthy Baseline Control (No Intervention) | No intervention | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Female, aged 20-40 years.
- Regular daily routine with relatively fixed wake-up and bedtimes, sufficient sleep (7-9 hours), regular diet, moderate physical activity, and avoidance of shift work.
- Intact structure of major organ systems, with no active diseases or pathological damage.
- Regular menstrual cycle (21-35 days) and normal menstrual period (3-7 days).
- For the experimental group (Qi Yu constitution group):
Key exclusion criteria (14 listed)
- Participation in any other clinical trial evaluation within the past 1 month.
- Presence of organic diseases, such as various malignant tumors, certain chronic diseases (heart disease, diabetes, anemia, etc.), certain gynecological diseases (uterine fibroids, endometriosis, severe mammary hyperplasia, etc.), or certain endocrine diseases (hyperthyroidism or hypothyroidism, etc.).
- Individuals with hypothalamic-pituitary-adrenal (HPA) axis dysfunction, such as those with endocrine diseases (e.g., hyper/hypothyroidism, Cushing's syndrome, congenital adrenal hyperplasia, primary chronic adrenocortical insufficiency).
- Individuals diagnosed with major depressive disorder or anxiety disorder, bipolar disorder, schizophrenia, etc.
- Use of antidepressants, anti-anxiety medications, glucocorticoids, or immunosuppressants within the past 4 weeks.
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 |
|---|---|---|
| Non-invasive Steam-warm Acupoint StimulationParticipants will use a self-use device to apply steam-warm acupoint stimulation at five acupoints (GV20/Baihui, PC6/Neiguan, LI4/Hegu, SP6/Sanyinjiao, LR3/Taichong). The device consists of a main body (Part A) containing a heating element and high-hardness non-woven protrusions, secured by a adjustable strap (Part B). Stimulation is applied for 20 minutes per session, 3 times per week. | Other | Steam-warm and Simple Acupressure Crossover Group |
| Non-invasive Pressure Acupoint StimulationParticipants will use a self-use device to apply pressure-only acupoint stimulation at the same five acupoints as above. The device is visually similar to the steam-warm device but Part A contains a non-heating, shaped hard sheet and high-hardness non-woven protrusions. It is secured by the same adjustable strap (Part B). Stimulation is applied for 20 minutes per session, 3 times per week. | Other | Steam-warm and Simple Acupressure Crossover Group |
| Placebo Acupoint StimulationParticipants will use a self-use device designed to mimic the active intervention devices in appearance. The device's Part A contains a non-heating, shaped hard sheet and low-hardness non-woven protrusions that deliver minimal pressure, secured by the same adjustable strap (Part B). It is applied to the same five acupoints for 20 minutes per session, 3 times per week. | Other | Placebo Control |
Primary outcome
Change in Perceived Stress Scale (PSS-14) Score
Time frame: From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4).
3 secondary outcomes
Change in Heart Rate Variability (HRV) Parameters during Acute Stress
Time frame: During each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention (Week 11, for the crossover group).
Change in Psychophysiological Response to the Montreal Imaging Stress Task (MIST)
Time frame: During each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention (Week 11, for the crossover group).
Change in Salivary Cortisol and 3-Methoxy-4-hydroxyphenylglycol (MHPG) Levels during Acute Stress
Time frame: Saliva samples are collected at multiple timepoints (T0, T15, T20, T25, T30 minutes) during each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention.
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 2 Apr 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Steam-warm Acupoint Stimulation and Non-invasive Pressure Acupoint Stimulation in people with Qi Stagnation Constitution and Acupoints, run by ChinaNorm 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 19 inclusion and 14 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: opening soon, as of the sponsor's last update on 2 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 Yanwen Jiang (13501700841, jiangyanwen@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS-14) Score (time frame: From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4).). 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 2 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.