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An Open-Label, Single-Arm Targeted Clinical Trial Evaluating the Safety and Efficacy of LED Red Light Therapy Devices in Clinical Practice

An Open-Label, Single-Arm Targeted Clinical Trial Evaluating the Safety and Efficacy of LED Red Light Therapy Devices in Clinical Practice

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116460
Enrollment
Unknown
Registered
2026-01-09
Start date
2022-04-21
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

Interventions

Patients with primary dysmenorrhea treated with LED red light therapy devices:LED Red Light Therapy

Sponsors

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1.female patients aged 13 to 35 years (inclusive); 2. diagnosis of primary dysmenorrhea; 3.regular menstrual cycles (28 +/- 7 days); 4.self-reported average pain visual analogue scale (VAS) score of >=4 during the most recent two menstrual cycles; 5.voluntary participation with written informed consent provided by the patient and/or legal guardian.

Exclusion criteria

Exclusion criteria: 1.Diagnosis of secondary dysmenorrhea confirmed by gynecological examination and abdominal ultrasonography due to gynecological conditions such as endometriosis, pelvic inflammatory disease, or adenomyosis, or other organic pathologies; 2.Use of oral contraceptives and/or centrally acting medications and/or receipt of physical therapy for dysmenorrhea within the past month; 3. Use of analgesic medications within 24 hours prior to evaluation; 4. Presence of skin ulcers, infections, or other abnormalities at the irradiation site; 5.Severe psychiatric or other disorders impairing the ability to accurately complete VAS pain assessments or objectively describe symptoms; 6.History of phototherapy allergy, malignant tumors, systemic lupus erythematosus, hemorrhagic/hemolytic diseases; 7.Pregnancy, lactation, or planned pregnancy within 3 months after enrollment; 8.Participation in other clinical trials (involving medical devices or pharmaceuticals) within the past month; 9. Other conditions deemed by the investigators to render the participant unsuitable for inclusion, such as anticipated poor compliance.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
COX Menstrual Pain Symptom Scale;Subject Experience Evaluation;VAS scores during the first, second, and third menstrual periods after subject enrollment;Efficiency rates during the first and second menstrual periods after subject enrollment.;

Countries

China

Contacts

Public ContactGuo Li

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Guoli0918@163.com+86 186 8612 9001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 3, 2026