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Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement

NCT07818044 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-22

Condition(s) studied

Primary Dysmenorrhea (PD)

Investigational drug(s) / intervention(s)

TI-816-3E3 Portable Laser Phototherapy DeviceTI-816-3E3 Portable Laser Phototherapy Device

TI-816-3E3 Portable Laser Phototherapy Device: 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 Device: 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 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.

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
30 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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). Exclusion Criteria: * Major Gynecological Conditions: 1. History of major gynecological disorders. 2. Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS). * Pharmacological Interference: 1. Long-term use of medications that affect the menstrual cycle. 2. Currently undergoing hormonal therapy or long-term administration of analgesics. * 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.

Primary outcome measure(s)

  • Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS) — 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).

Trial sites (1)

FacilityCityRegionStatus
China Medical University Hospital Taichung Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07818044 on ClinicalTrials.gov ↗ ← All trials in China