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Gold needle for breast pain

Study on the clinical efficacy and safety of Wang's gold needle penetrating needling in the treatment of breast hyperplasia with non-periodic breast pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070609
Enrollment
Unknown
Registered
2023-04-18
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Hyperplasia of mammary glands

Interventions

Gold needle treatment group:Gold needle therapy
Watchful waiting group:No needle

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Patients meeting the above diagnostic criteria for cyclomastopathy; 2) Non-periodic breast pain, with VAS score (pain visual analogue scale) of =4 points, i.e., moderate to severe pain; 3) Breast ultrasound: breast nodules of BI-RADS grade 2–3 and considered as hyperplasia of mammary glands nodules; 4) Women aged 30–55 years old, with the disease course of 3 months–5 years; Patients with regular menstrual cycles (28±7 days) and menstrual periods (3–7 days); 5) Informed consent form was signed and the participants were volunteers. The informed consent process met the requirements of GCP.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Other diseases causing breast pain, such as chest wall pain, gallstones, gastroesophageal reflux disease, cervical radiation pain, angina pectoris, breast abscess, and breast cancer; Breast fibroadenoma, breast cancer and other causes of breast lumps; 3) Those who have received acupuncture and moxibustion treatment within six months or taken hormone drugs to treat breast diseases; 4) Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system as well as mental illness; 5) Those who are intolerant to acupuncture or have a history of acupuncture sickness; 6) patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;Simplified McGill Pain Questionnaire;

Secondary

MeasureTime frame
Maximum nodule volume;The number of breast nodules;Number of Fenbid Tablets taken;

Countries

CHINA

Contacts

Public ContactXue Liwen

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

xueliwen@sina.com+86 13671027327

Outcome results

None listed

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