Primary Dysmenorrhea (PD)NCT07818044
Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement
A study testing TI-816-3E3 Portable Laser Phototherapy Device in people with Primary Dysmenorrhea (PD), run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- TI-816-3E3 Portable Laser Phototherapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Aug 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 female participants with a history of primary dysmenorrhea symptoms.
- 20 healthy female controls without significant dysmenorrhea symptoms.
- Age Range: Females aged 18-30 years.
- Menstrual Regularity: Regular menstrual cycles, defined as a cycle duration of 21-35 days.
- Menstrual Stability: Relatively stable menstrual patterns within the past 3 months.
- Informed Consent \& Compliance: Willingness to comply with all measurement and intervention protocols, and provided signed written informed consent.
- Medication Management: Agreeing not to use additional analgesics or traditional conditioning treatments during the intervention period (or agreeing to accurately report and record any use).
Who cannot join
- Major Gynecological Conditions:
- History of major gynecological disorders.
- Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS).
- Pharmacological Interference:
- Long-term use of medications that affect the menstrual cycle.
- Currently undergoing hormonal therapy or long-term administration of analgesics.
Show all 9Show fewer
- Physiological States: Pregnancy or current breastfeeding.
- General Health Status: Recent acute systemic inflammation or major systemic illnesses.
- Prior Treatment Confounding: Recent receipt of intensive acupuncture, moxibustion, or related meridian-based therapies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
China Medical University Hospital
Taichung, 404327
Yu-Chen Lee, 886-4-2205-3366 ext. 3500, 005167@tool.caaumed.org.tw
Yu-Chen Lee
About this study
Official title: Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design and Feasibility Assessment Based on Meridian Measurement
Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations.
This pilot study aims to evaluate the feasibility, preliminary efficacy, and physiological responses of an individualized meridian-guided intervention for primary dysmenorrhea in females aged 18-30. Utilizing non-invasive skin electrical resistance measurements (AETOSCAN) to assess baseline meridian energy status, eligible dysmenorrhea participants will be randomized into two parallel arms: an individualized meridian-guided intervention group and a standardized fixed-acupoint group. Interventions will be administered twice weekly over a 4-week cycle. The primary outcomes focus on changes in pain severity (VAS), menstrual distress scores (MDQ), and objective meridian electrical characteristics.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- TI-816-3E3 Portable Laser Phototherapy Device
- Keywords
- Laser Acupuncture, Electrical Skin Resistance, Meridian Diagnosis, Individualized Acupuncture, Traditional Chinese Medicine, Menstrual Distress Questionnaire, Visual Analog Scale, Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI-816-3E3 Portable Laser Phototherapy DeviceDevice
Application of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks.
TI-816-3E3 Portable Laser Phototherapy DeviceDevice
Application of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Control: Standard Acupoint Group | Active comparator | Participants in this arm receive standardized, fixed-acupoint laser acupuncture (or sham-like press-needle/seeding on standard dysmenorrhea points such as SP6, CV4, CV6) regardless of their individual meridian electrical resistance profile. Receives: Device: TI-816-3E3 Portable Laser Phototherapy Device |
| Experimental: Individualized Meridian-Guided Group | Experimental | Participants in this arm receive individualized laser acupuncture based on real-time meridian electrical resistance measurements using AETOSCAN prior to each intervention session. Receives: Device: TI-816-3E3 Portable Laser Phototherapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a 0-100 mm continuous scale used to measure subjective menstrual pain severity (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain intensity.
Time Frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Measured: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Secondary outcomes (2)
Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)
The MDQ Form C consists of 46 items across 8 subscales assessed on a 5-point Likert scale (0 = no symptom to 4 = severe symptom). Total scores range from 0 to 184, with higher scores reflecting greater menstrual distress.
Measured: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Change in Meridian Electrical Resistance Profiles
Objective skin electrical resistance (in microamperes, µA) measured across twelve primary meridian Yuan-Source points using the AETOSCAN system to assess systemic physiological energy shifts.
Measured: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea (PD)Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818044
- Sponsor's protocol ID
- CMUH115-REC2-152
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design and Feasibility Assessment Based on Meridian Measurement
- ClinicalTrials.gov ID
- NCT07818044
- Acronym / sponsor ID
- CMUH115-REC2-152
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Laser Acupuncture, Electrical Skin Resistance, Meridian Diagnosis, Individualized Acupuncture, Traditional Chinese Medicine, Menstrual Distress Questionnaire, Visual Analog Scale, Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Sep 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.
Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations.
This pilot study aims to evaluate the feasibility, preliminary efficacy, and physiological responses of an individualized meridian-guided intervention for primary dysmenorrhea in females aged 18-30. Utilizing non-invasive skin electrical resistance measurements (AETOSCAN) to assess baseline meridian energy status, eligible dysmenorrhea participants will be randomized into two parallel arms: an individualized meridian-guided intervention group and a standardized fixed-acupoint group. Interventions will be administered twice weekly over a 4-week cycle. The primary outcomes focus on changes in pain severity (VAS), menstrual distress scores (MDQ), and objective meridian electrical characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control: Standard Acupoint Group | Active comparator | Device: TI-816-3E3 Portable Laser Phototherapy DeviceParticipants in this arm receive standardized, fixed-acupoint laser acupuncture (or sham-like press-needle/seeding on standard dysmenorrhea points such as SP6, CV4, CV6) regardless of their individual meridian electrical resistance profile. |
| Experimental: Individualized Meridian-Guided Group | Experimental | Device: TI-816-3E3 Portable Laser Phototherapy DeviceParticipants in this arm receive individualized laser acupuncture based on real-time meridian electrical resistance measurements using AETOSCAN prior to each intervention session. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 20 female participants with a history of primary dysmenorrhea symptoms.
- 20 healthy female controls without significant dysmenorrhea symptoms.
- Age Range: Females aged 18-30 years.
- Menstrual Regularity: Regular menstrual cycles, defined as a cycle duration of 21-35 days.
- Menstrual Stability: Relatively stable menstrual patterns within the past 3 months.
Key exclusion criteria (9 listed)
- Major Gynecological Conditions:
- Pharmacological Interference:
- Physiological States: Pregnancy or current breastfeeding.
- General Health Status: Recent acute systemic inflammation or major systemic illnesses.
- Prior Treatment Confounding: Recent receipt of intensive acupuncture, moxibustion, or related meridian-based therapies.
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 |
|---|---|---|
| TI-816-3E3 Portable Laser Phototherapy DeviceApplication of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks. | Device | Active Control: Standard Acupoint Group |
| TI-816-3E3 Portable Laser Phototherapy DeviceApplication of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks. | Device | Experimental: Individualized Meridian-Guided Group |
Primary outcome
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
Time frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
The Visual Analog Scale (VAS) is a 0-100 mm continuous scale used to measure subjective menstrual pain severity (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain intensity. Time Frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
2 secondary outcomes
Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)
Time frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Change in Meridian Electrical Resistance Profiles
Time frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
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 22 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI-816-3E3 Portable Laser Phototherapy Device in people with Primary Dysmenorrhea (PD), run by China Medical University Hospital at 1 site in Taiwan.
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 7 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: opening soon, as of the sponsor's last update on 22 Sep 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 Taiwan. 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 JING-YUN KANG (886-983726861, likestecla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS) (time frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).). 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 22 Sep 2026.