Skip to content

Ruhe Sanjie tablet in the treatment of hyperplasia of breast was randomized double-blind placebo parallel control

Ruhe Sanjie tablet in the treatment of hyperplasia of breast was randomized double-blind placebo parallel control

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000348
Enrollment
Unknown
Registered
2024-09-02
Start date
2024-05-30
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperplasia of mammary glands

Interventions

observation group:Ruhe Sanjie tablet
control group:placebo

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above diagnostic and syndrome differentiation criteria; (2) Women aged 18-60; (3) Patients who have not received drug treatment related to breast hyperplasia in the past 1 month and have not used hormone drug treatment in the past 6 months; (4) Not participating in other related clinical trials; (5) Sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with acute breast inflammation and breast fibroadenoma; (2) There is a tendency of breast cancer or breast malignancy, or a history of breast cancer; (3) Patients with serious cardiovascular, cerebrovascular, hematopoietic and other primary diseases and mental diseases; (4) Pregnant or lactating women and those who have a pregnancy plan in the past 3 months; (5) Patients with long-term use of endocrine, anti-inflammatory analgesic, antipsychotic drugs; (6) Menstrual cycle is not according to the monthly regularity of the tide, such as polycystic ovary syndrome, uterine fibroids; Taking contraceptives and sex hormone drugs; (7) Allergic to the test drug and its ingredients; (8) The subjects are unwilling to participate in the study or do not cooperate with treatment; (9) The researcher considers it inappropriate to participate.

Design outcomes

Primary

MeasureTime frame
Pain and mass score improvement rate;

Secondary

MeasureTime frame
The number, texture, size and scope of breast mass changed;Breast color B-ultrasound detection;Hamilton Anxiety and Depression Scale;TCM syndrome score of accompanying symptoms;Sex hormone test;

Countries

China

Contacts

Public ContactGAO Xiang

Dongzhimen Hospital Beijing University of Chinese Medicine

18810379605@126.com18810379605

Outcome results

None listed

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