Effectiveness and safety of Hongjin Xiaojie Capsule versus waiting list for breast pai

Phase 4

Completed

• Conditions: Breast pain; Signs and Symptoms

• Registration Number: ISRCTN44184398
• Lead Sponsor: Yunnan Yousheng Pharmaceutical Co., Ltd

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39232973/ (added 06/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-18
• Study Completion: 2021-12-31
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 298

Inclusion Criteria

1. 18 - 55 years old, female, pre- or peri-menopause
2. Meeting the diagnostic criteria of breast pain; including women with breast nodules, the longest diameter of B-ultrasonic solid nodules =2cm or the longest diameter of B-ultrasonic cystic nodules =2 cm
3. The number of days of breast pain for each menstrual cycle is equal or longer than 3 days and visual analog scale (VAS) = 4 points; if treated before, the pain symptom could not relieve for three consecutive menstrual cycles or more
4. Women diagnosed as hysteromyoma according to the diagnostic criteria of hysteromyoma will be included
5. The menstrual cycle and the menstrual period are basically regular, and the menstrual cycle is about 28 ± 7 days

Exclusion Criteria

1. Women who are preparing for pregnancy or who are pregnant or lactating
2. Patients with allergic constitution, or allergic to the test drug or its components
3. Breast image report and data system (BI-RADS) classification > level 3
4. Patients with breast malignant tumors, inflammatory diseases and other endocrine diseases (such as pituitary tumors)
5. Taking contraceptives during the trial and using hormonal drugs within the first three months of screening
6. Those who have taken Chinese or Western medicines to treat this disease within 1 month before screening or those who participated in other clinical drug trials
7. Patients with severe primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or patients with mental illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The degree of breast pain measured using short-form of McGill questionnaire (SF-MPQ) at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up)<br>2. The duration of pain: the number of days of breast pain during each menstrual cycle measured at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up)