Clinical Trial of Ruxian Zengsheng No. 1 Decoction

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

A prospective, open, randomized, controlled phase II clinical study is planned to clarify the efficacy and related adverse reactions of Mammary Glandular Hyperplasia No. 1 Decoction in the treatment of liver-qi stagnation type breast hyperplasia, relieve the pain of patients with breast hyperplasia, and improve the quality of life of patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiuda Zhao

Criteria

Inclusion Criteria:

1. Healthy women over 18 years of age;

2. Patients who meet the diagnostic criteria for breast color Doppler ultrasound diagnosis of breast hyperplasia and the course of disease exceeds 3 months;

3. Meet the syndrome differentiation criteria for liver-stagnation and qi stagnation (main symptoms are ① breast distension Pain and pain; ② breast pain and/or lumps are related to menstruation and mood changes; ③ irritability and irritability; ④ flank fullness. Secondary symptoms: ① the lumps are single, soft and tender; ② Young women; ③Irregular menstruation or dysmenorrhea; ④Pale red tongue, thin white or thin yellow coating, stringy pulse. With 3 main symptoms or 2 main symptoms + 2 secondary symptoms);

4. breast color ultrasound, breast molybdenum Target, or breast MRI showed BI-RADS 2-3;

5. NRS (0-10 pain rating) score ≥ 4 points on the most painful day before treatment, according to the score, the pain is divided into mild 3 points, moderate Grade 4-6 points, severe 7-10 points;

6. Voluntarily participate in the clinical study and sign the informed consent form after the informed consent (patients voluntarily accept the study and sign the informed consent).

Exclusion Criteria:

1. Patients with other breast diseases or other causes of breast pain (such as mastitis, breast cancer, etc.);

2. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumors, blood system diseases, and Patients with mental illness;

3. Patients who have been confirmed to have dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before treatment, still need to regulate hormone levels for treatment;

4. Patients diagnosed with hypercortisolism before treatment still need bromocriptine treatment;

5. Menstrual period is more than 7 days, menopause and severe irregular menstrual cycle;

6. ALT, AST, ALP, TBIL , GGT is higher than the upper limit of normal; or abnormal blood, urine, electrocardiogram and other examination items;

7. pregnant or breastfeeding women, or patients with pregnancy plans in the next six months;

8. 1 before treatment Use Chinese or Western medicine to treat breast hyperplasia (including painkillers, topical drugs, acupuncture, etc.) within the month and during the treatment period, and use hormonal drugs (except for long-term use), and oral contraceptives within six months;

9. People who are known to be allergic to the ingredients of the test drug prescription;

10. Past alcohol or drug abuse history;

11. Patients who participated in other clinical studies within 3 months before enrollment;

12. According to the judgment of the researchers, there are other diseases Or circumstances will reduce the possibility of enrollment or complicate enrollment. For example, frequent changes in the work environment may cause loss to follow-up, and patients with mental and behavioral disorders, or the inability to sign informed consent.