Danlu Capsule in the treatment of mammary gland hyperplasia (imbalance of charge and discharge, stagnation and phlegm syndrome) multi-center, open, single-arm phase IV clinical trial

Phase 4

Completed

• Conditions: Hyperplasia of mammary gland (imbalance of charge and discharge, stagnation and phlegm syndrome); N62 03

• Registration Number: ITMCTR2000003543
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

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: Completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meet the diagnostic criteria of mammary gland hyperplasia in western medicine;
(2) Meet the standard of TCM syndrome differentiation of imbalance of charge and discharge,stagnation and phlegm syndrome;
(3) At least 18 years old;
(4) Informed consent, volunteer and sign the informed consent.

Exclusion Criteria

(1) In gestation period , suckling period, serious menstrual disorder, functional uterine bleeding women;)
(2) Patients with breast inflammation, breast malignant tumor and simple benign tumor;
(3) Prophylactic and sex hormone user;
(4) Serious heart, liver, kidney disease or hematopoietic system disease, mental patient;
(5) Allergic constitution or allergic to the ingredients of the medicine used in this trial;
(6) Having a pregnancy plan within 3 months;
(7) Participated in other clinical trials within 3 months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Breast tumor size;Routine blood test;Breast pain;Urine routine test;

Secondary Outcome Measures

Name	Time	Method
TCM Comprehensive Treatment;TCM syndromes score;