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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)

A multi-center, open, single-arm phaseiv 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)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004884
Enrollment
Unknown
Registered
2021-05-26
Start date
2021-06-14
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

Hyperplasia of mammary gland

Interventions

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pregnancy test;Urinary routine;renal function;liver function;12-lead electrocardiogram;Routine blood test;

Countries

China

Contacts

Public ContactZhang Dongxiao
morningdong@163.com+86 13811077684

Outcome results

None listed

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