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Preliminary evaluation of effectiveness and safety of shuganjieyu acupuncture in the treatment of cyclic mastalgia

Preliminary evaluation of effectiveness and safety of shuganjieyu acupuncture in the treatment of cyclic mastalgia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073679
Enrollment
Unknown
Registered
2023-07-18
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

cyclical mastalgia

Interventions

manual acupuncture group:acupuncture(Wuyi, Rugen, Tanzhong, Ashi acupoint, Tianzong, Geshu, Ganshu, Hegu, Sanyinjiao, Taichong. Treatment begins two weeks before menstruation, and acupuncture stops wh
sham acupuncture group:sham acupuncture(Non meridian non acupoint points, specifically as follows: 2 inches below the thoracic 6-12 spinous process, hip groove to the midpoint of the popliteal transve

Sponsors

Beijing Traditional Chinese medicine Hospital Pinggu Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1)Aged 18-45 years old; (2) Meets diagnostic criteria: Breast pain occurs 2 weeks before menstruation and improves after menstruation, with bilateral dullness, heaviness, or pain. (3)Satisfy all the following conditions: 1) Daily average overall breast pain visual analog score (VAS-BP) = 3 points; 2) The number of days of premenstrual breast pain is = 3 days and = 14 days; 3) The basic rules for menstrual cycles are (28 ± 7) days and 3-7 days. (4)Breast X-ray or breast ultrasound examination is excluded from malignant breast lesions; (5)The patient signed the informed consent and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: ? Not receiving relevant treatment within the past month; ? Other benign breast lesions such as breast inflammation, breast fibroma, and cystic hyperplasia of the breast; ? Patients with severe cardiovascular and cerebrovascular diseases, severe damage to liver and kidney function, or coagulation dysfunction; ? No history of breast cancer in first-degree relatives; ? Breast pain related diseases such as rib cartilage inflammation, chest wall injury, rib fractures, etc; ? Patients in pregnancy or lactation stage; ? Patients with communication barriers or severe mental illness; ? Therapists currently participating in other studies; ? Severe skin disease or infection at the intended acupuncture site.

Design outcomes

Primary

MeasureTime frame
Breast Pain Visual Analog Scale;

Secondary

MeasureTime frame
the number of nominal days of breast pain;WHOQOL-BREF;Evaluation of the patient's global improvement;breast glandular section thickness, and breast duct width;Elastic hardness e value of breast tissue;

Countries

China

Contacts

Public ContactYuchuan

Beijing Traditional Chinese medicine Hospital Pinggu Hospital

yuchuan106@126.com+86 138 1151 5259

Outcome results

None listed

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