A randomized, double-blind, prospective clinical study of Weiru Xitong ointment in the treatment of breast hyperplasia

Phase 1

Recruiting

• Conditions: Breast hyperplasia

• Registration Number: ITMCTR2000003364
• Lead Sponsor: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of breast hyperplasia;
2. Patients with previous periodic premenstrual pain had VAS score >= 4 and duration >= 3 months;
3. Premenopausal women aged 18-55 years (inclusive);
4. In the past three months, the patients who did not use Chinese and Western drugs to treat breast hyperplasia and relieve breast pain did not use hormone preparations, oral contraceptives and hormone replacement therapy drugs in the past six months;
5. Clinical physical examination of breast, at least one patient with palpable nodule or breast thickening;
6. The local skin of breast is normal without damage;
7. Patients who voluntarily accept the clinical trial and sign the informed consent.

Exclusion Criteria

1. Patients who meet the diagnostic criteria of breast hyperplasia but do not have periodic breast pain symptoms;
2. Patients with mastitis, breast cancer and other breast diseases with surgical indications;
3. Patients who have had breast plastic surgery or breast surgery in the past 3 months;
4. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, peptic ulcer or serious diseases (such as tumor or AIDS) affecting their survival, or mental or legal disabilities;
5. Patients with ovariectomy (in whole or in part);
6. Patients with chest pain caused by other diseases;
7. Pregnant or lactating women, or patients with pregnancy plans in the past three months;
8. Patients who are allergic to constitution or known to be allergic to components of the prescription of the drug;
9. According to the judgment of the researchers, other diseases that may reduce the possibility of enrollment or complicate the enrollment, such as changes in the working environment, which may easily lead to loss of interview, as well as insufficient informed consent due to mental and behavioral disorders;
10. Patients who participated in other clinical trials in the past month.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
McGill pain questionnaire;