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Evaluation of the safety and efficacy of semiconductor laser irradiation at Guanyuan point in the treatment of primary dysmenorrhea: a randomized, double-blind, placebo-controlled trial

Evaluation of the safety and efficacy of semiconductor laser irradiation at Guanyuan point in the treatment of primary dysmenorrhea: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046199
Enrollment
Unknown
Registered
2021-05-09
Start date
2021-05-15
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Primary dysmenorrhea

Interventions

Sponsors

Nanjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as primary dysmenorrhea according to the primary dysmenorrhea management guidelines issued by the Society of Obstetricians and Gynecologists of Canadian in 2017; 2. Females aged 18 to 30 years who have not given birth; 3. Menstrual cycle regularity: 28±7 days; 4. Periodic pain during menstruation for 6 months and above; 5. The average pain score of the Visual Analogue Scale (VAS) of the last 3 menstrual cycles is >=4 points; 6. Volunteer to participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary dysmenorrhea caused by gynecological diseases such as endometriosis, pelvic inflammatory disease, adenomyosis or other diseases confirmed by gynecological examination and B-ultrasound; 2. Oral contraceptives or drugs that act on the central nervous system within 1 month before treatment, or have received relevant physical therapy; 3. Are participating in or have participated in other drugs or other types of clinical trials within the past 1 month; 4. There are abnormalities such as ulceration and infection in the skin of the irradiation site; 5. Suffering from severe mental or other diseases, unable to correctly score the pain or unable to objectively describe the symptoms; 6. History of phototherapy allergy; 7. Women who are pregnant, breastfeeding or planning to become pregnant; 8. There are objections to the treatment of this trial or the inability to receive regular follow-ups.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;

Secondary

MeasureTime frame
Epoxidase dysmenorrhea symptom scale score;Time and degree of lower abdomen pain;Self-rating anxiety scale;Self-rating depression scale;

Countries

China

Contacts

Public ContactLu Lijuan

Nanjing Drum Tower Hospital The Affiliated Hospital Of Nanjing University Medical School

932200932@qq.com+86 18606190038

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026