A prospective, randomized, double-blind, parallel, placebo-controlled, multicenter clinical study of acupoint application in the treatment of hyperplasia of mammary glands
- Conditions
- Mammary gland hyperplasia
- Registration Number
- ITMCTR2200005622
- Lead Sponsor
- Affiliated Hospital of Shandong University of Traditional Chinese medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method iver and kidney function;Ekg;CBC;Severity and incidence of adverse events;Vital signs T\P\R\BP;Urine routine;Stool routine;