A multi-center, open, single-arm phase iv clinical trial on the safety and effectiveness of Rujietai capsule in the treatment of hyperplasia of mammary glands (liver stagnation and qi stagnation, and phlegm coagulation and blood stasis)

Phase 4

Recruiting

• Conditions: Hyperplasia of mammary gland

• Registration Number: ITMCTR2100004884
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

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. Meet the diagnostic criteria for breast hyperplasia;
2. In line with the traditional Chinese medicine syndrome differentiation standards of liver stagnation, qi stagnation and spittoon coagulation and blood stasis;
3. Female aged 18 to 55 years(including 18 and 55);
4. Breast color ultrasound BI-RADS rating <=3;
5. Voluntarily participate in the clinical trial, give informed consent and sign informed consent.

Exclusion Criteria

1. Diseases requiring sex hormone therapy, such as dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactimia, etc.;
2. Complicated with heart, lung, brain, liver, kidney, hematopoietic system and other serious primary diseases, mental diseases;
3. ALT or AST is 1.5 times greater than the upper limit of the normal reference value, or Cr is greater than the upper limit of the normal reference value;
4. Menstrual period of more than 7 days, menopause, severe disorder of menstrual cycle;
5. Pregnant and lactating women who are not willing to take effective measures to prevent pregnancy during the trial and within 3 months after the end of the trial;
6. The contraceptive method is drug contraception;
7. Have a history of allergy to test drug ingredients;
8. A history of long-term alcohol and drug abuse;
9. having intellectual or mental retardation;
10. Participated in other clinical trials within the last 3 months;
11. The investigator did not consider it appropriate to participate in this clinical trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pregnancy test;Urinary routine;renal function;liver function;12-lead electrocardiogram;Routine blood test;