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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003364
Enrollment
Unknown
Registered
2020-05-30
Start date
2020-06-08
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

Breast hyperplasia

Interventions

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
McGill pain questionnaire;

Countries

China

Contacts

Public ContactQianjun Chen

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

cqj55@163.com+86 18688883505

Outcome results

None listed

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