An interventional study of Non-invasive Steam-warm Acupoint Stimulation and Non-invasive Pressure Acupoint Stimulation in Qi Stagnation Constitution and Acupoints, sponsored by ChinaNorm. Not yet recruiting at 1 site in China. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by ChinaNorm · Not applicable, Interventional, and Prevention
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.
ChinaNorm is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the experimental group (Qi Yu constitution group):
Diagnosis by a qualified TCM physician according to standard procedures, confirming characteristics of Qi Yu constitution, including (physical symptoms partially required):
For the control group (non-Qi Yu constitution group):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-invasive acupoint stimulation
Other: Non-invasive Steam-warm Acupoint Stimulation · Other: Non-invasive Pressure Acupoint Stimulation
Other: Placebo Acupoint Stimulation
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.
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.
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.
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).
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.
Change in Medial Prefrontal Cortex (mPFC) Activation during Acute Stress measured by fNIRS
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 Subjective Pressure Level measured by Visual Analogue Scale (VAS)
Time frame: Assessed at multiple time points 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 Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: At Baseline (Week 0), after the first 4-week intervention (Week 4), after the 3-week washout (Week 7), and after the second 4-week intervention (Week 11, for the crossover group).
Change in Depression Symptoms measured by Self-Rating Depression Scale (SDS)
Time frame: At Baseline (Week 0), after the first 4-week intervention (Week 4), after the 3-week washout (Week 7), and after the second 4-week intervention (Week 11, for the crossover group).
Change in Self-Rating Anxiety Scale (SAS) Score
Time frame: From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7).
Change in Sub-Health Measurement Scale Version 1.0 (SHMS V1.0) Score
Time frame: From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7).
Change in Health Status Questionnaire (Qi Yu Constitution) Score
Time frame: From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7).
Change in University of California, Los Angeles Loneliness Scale (UCLA) Score
Time frame: From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7).
Plan to share: No
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