Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT04229706
Eligibility Criteria:
Inclusion Criteria:
1. Female patients aged 18-50 years.
2. Those who meet the diagnostic criteria of breast hyperplasia and has a course of more than 3 months;
3. Conform to the syndrome differentiation standard of liver depression and phlegm coagulation;
4. Patients have a basic regular menstrual cycle (21-35 days) and a menstrual period (3-7 days)
5. BI-RADS grade 2-3
6. NRS score ≥ 4 points in screening period
7. The average score of NRS was ≥ 4 in the run-in period, and there was still a target lump in palpation
8. Volunteer to participate in the experiment and sign the informed consent form after informed consent（Patients voluntarily accepted the test and gave 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 tumor, blood system diseases and mental diseases.
3. Patients who have been confirmed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before, still need to be treated by regulating hormone level.
4. Patients with previously confirmed hypercortisolism who still need to be treated with bromocriptine.
5. Those with menstrual period more than 7 days, menopause and serious irregular menstrual cycle.
6. Alt, AST, ALP, TBIL, GGT more than 1.2 times the upper limit of normal value; serum Cr, bun more than 1.2 times the upper limit of normal value, or blood, urine routine, ECG and other examination items are abnormal and of clinical significance.
7. That who pregnant or lactating women, or have a pregnant plan within the next 6 months
8. Chinese or Western medicine was used to treat hyperplasia of mammary gland within 1 month before the treatment and during run-in period(including external application medicine, acupuncture, etc.) and hormone drugs have been used within half a year (except for long-term oral contraceptives).
9. Allergic constitution, known to be allergic to the ingredients of the prescription of the test drug
10. History of alcohol or drug abuse.
11. Participants in other clinical trials within 3 months before screening
12. According to the judgment of the researchers, there are other diseases or situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, which are likely to cause lost visits, and people with mental and behavioral disorders that cannot be based on the full informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04229706
Study Brief:
Protocol Section:
NCT04229706