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A clinical randomized controlled study on the treatment of breast hyperplasia with FSN

A clinical randomized controlled study on the treatment of breast hyperplasia with FSN

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078976
Enrollment
Unknown
Registered
2023-12-22
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Hyperplastic disease of breast

Interventions

Fu's subcutaneous needling :Fu's subcutaneous needling therapy
Shovel needle group:Shovel needling therapy
Blank control group:Health promotion

Sponsors

The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 45 Years

Inclusion criteria

Inclusion criteria: ? Meets the diagnostic criteria and traditional Chinese medicine syndrome differentiation classification for breast hyperplasia; ? Age range from 25 to 45 years old (including 25 and 45 years old); ? Diagnosed as breast hyperplasia through color ultrasound examination, the grading of breast nodules is within Bi RADS3 level; ? The subjects voluntarily participate in the experiment, agree and sign an informed consent form; ? Do not participated in any other clinical studies and guarantee not to participate in any other clinical studies during this study period. Note: Only those who meet the above 5 criteria can be included in this study.

Exclusion criteria

Exclusion criteria: ? Not meeting the above diagnostic criteria and inclusion criteria; ? Under 25 years old or over 45 years old; ? Patients with severe cardiovascular, cerebrovascular, liver, kidney, or hematopoietic system diseases; ? Those who have been diagnosed with breast malignancy through relevant laboratory tests; Or ultrasound shows that the grading of breast nodules is greater than Bi RADS3 grade; ? Pregnant and lactating women; ? Individuals who have a resistance to acupuncture treatment; ? Individuals with mental illness or lack of cooperation, as well as those with continuously worsening conditions or serious complications during the trial; ? Individuals who have received other relevant treatments; ? Breast inflammation or severe infection. Note: Anyone who meets any of the above criteria should be excluded.

Design outcomes

Primary

MeasureTime frame
Visual Analog Pain Scale (VAS);Breast ultrasound;Hamilton Anxiety Scale;Hamilton Depression Scale;

Secondary

MeasureTime frame
Six items of sex hormones;KPS;Barthel Index;

Countries

China

Contacts

Public ContactRen Zhen

The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine

13272078889@163.com+86 132 7207 8889

Outcome results

None listed

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