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

Phase 1

• Conditions: Benign breast tumor

• Registration Number: ITMCTR2000003074
• Lead Sponsor: Shanghai hospital of traditional Chinese medicine

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: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The degree of pain;Nodule size;integral;