Clinical trial NCT04229706: A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperplasia of Breast
Keywords: hyperplasia of breast
Xiangjurupining capsule
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients .

Detailed description: The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule,give three times a day versus placebo in Hyperplastic disease of breast patients .The clinical phase of the study comprises a run-in period，an 3-months double-blind treatment period and a 1-month follow-up period, resulting in 5-months overall duration of the study for each patient.

Patients report their breast pain as measured using NRS scale on the subject daily diary。

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.

Primary outcomes:
measure: The pain of breast
timeFrame: up to 3 months
measure: The days of pain
timeFrame: up to 3 months
measure: The target lump
timeFrame: 3 months after treatment
measure: The target lump area
timeFrame: 3 months after treatment
measure: TCM syndrome scores
timeFrame: 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Baoding
country: China
facility: Baoding No.1 Hospital of TCM
city: Beijing
country: China
facility: Dongfang Hospital ,Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Dongzhimen Hospital,Beijing University of Chinese Medicine
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of TCM
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou University of TCM
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: SHUGUANG Hospital, Shanghai University of Traditional Chinese Medicine
city: Weifang
country: China
facility: Weifang Traditional Chinese Hospital
Study officials:
References: