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Clinical standardization of a new type of traditional Chinese medicine ''ru-he-san'' gel in the treatment of benign breast tumors

Clinical standardization of a new type of traditional Chinese medicine ''ru-he-san'' gel in the treatment of benign breast tumors

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030444
Enrollment
Unknown
Registered
2020-03-02
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-03-09

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

Conditions

Benign breast tumor

Interventions

Sponsors

Shanghai hospital of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria; Benign breast nodules with or without minimally invasive ablation; 2. The menstrual cycle is relatively stable; 3. Women aged between 18 and 55 (including 18 and 55); 4. the course of disease more than 3 months; 5. In the past month did not use the treatment of mammary gland disease of Chinese and western drugs, half a year did not use hormone preparations; 6. Voluntarily accept the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. menstrual dripping, menstrual period more than 7 days, or menopause, menstrual cycle is seriously irregular; 2. Patients with malignant breast tumors, mastitis and other breast diseases with traditional surgical indications; 3. complicated with cardio-cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases, or gastrointestinal ulcer disease, or affect its survival of serious diseases (such as tumor or AIDS), or mentally or legally disabled; 4. abnormal laboratory indicators: ALT, AST, BUN exceeded the upper limit of the normal value of 20%; Other abnormal laboratory indicators with clinical significance; 5. pregnant or nursing women; 6. Allergic constitution, or known allergic to the drug prescription components; 7. According to the judgment of the researcher, there are other lesions that reduce the possibility of inclusion or complicate inclusion, such as frequent changes in the working environment, which may easily lead to loss of follow-up.

Design outcomes

Primary

MeasureTime frame
Nodule size;The degree of pain;integral;

Countries

China

Contacts

Public ContactWang Xiaoping

Shanghai hospital of traditional Chinese medicine

prowxp@163.com+86 18801876545

Outcome results

None listed

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