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A prospective, randomized, double-blind, parallel, placebo-controlled, multicenter clinical study of acupoint application in the treatment of hyperplasia of mammary glands

Clinical study on appropriate acupoint application for diseases and syndromes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005622
Enrollment
Unknown
Registered
2022-02-08
Start date
2022-02-08
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Mammary gland hyperplasia

Interventions

Control Group:Placebo patch Chinese medicine powder placebo acupoint application
Test Group:Detumescence analgesic paste Chinese medicine powder acupoint paste

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Women aged between 18 and 45; 2. Meet the above diagnostic criteria of traditional Chinese Medicine and Western Medicine; 3. Participants who volunteered for the study did not take any other drug related to breast hyperplasia during treatment. 4. Informed Consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with Severe Menstrual Cycle Disorder; 2. Breast Inflammation, breast cancer; 3.3 months with a pregnancy plan; 4. And has the serious primary disease and so on serious heart brain blood vessel and liver kidney and hematopoiesis system; 5.3 months Oral Treatment Breast Disease Related Person; 6. Patients with other diseases requiring conventional treatment; 7. Pastes the place to have the skin wound, the ulcer, the skin infection or the scar constitution person and to the pastes allergic person. Note: The above items meet any 1 or more items should be excluded, can not be selected.

Design outcomes

Primary

MeasureTime frame
Breast Pain (Vas Score);Detection of serum sex hormone level;Degree of nipple discharge;Size, hardness and distribution of breast masses;Clinical efficacy;Integral of TCM Syndrome;Integration of quality of life scale: SF-36 scale;Color doppler ultrasound of mammary gland;

Secondary

MeasureTime frame
Liver and kidney function;Ekg;CBC;Severity and incidence of adverse events;Vital signs T\P\R\BP;Urine routine;Stool routine;

Countries

China

Contacts

Public ContactLiu Xiaofei
drliuxf@126.com15615611377

Outcome results

None listed

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