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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 180
- Locations
- 8
- Primary Endpoint
- The target lump
Study Overview
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。
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 18-50 years.
- •Those who meet the diagnostic criteria of breast hyperplasia and has a course of more than 3 months;
- •Conform to the syndrome differentiation standard of liver depression and phlegm coagulation;
- •Patients have a basic regular menstrual cycle (21-35 days) and a menstrual period (3-7 days)
- •BI-RADS grade 2-3
- •NRS score ≥ 4 points in screening period
- •The average score of NRS was ≥ 4 in the run-in period, and there was still a target lump in palpation
- •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
- •Patients with other breast diseases or other causes of breast pain, such as mastitis, breast cancer, etc.
- •Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumor, blood system diseases and mental diseases.
- •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.
- •Patients with previously confirmed hypercortisolism who still need to be treated with bromocriptine.
- •Those with menstrual period more than 7 days, menopause and serious irregular menstrual cycle.
- •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.
- •That who pregnant or lactating women, or have a pregnant plan within the next 6 months
- •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).
- •Allergic constitution, known to be allergic to the ingredients of the prescription of the test drug
- •History of alcohol or drug abuse.
- •Participants in other clinical trials within 3 months before screening
- •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.
Arms & Interventions
High dose group
xiangjurupining capsule ,8 capsules，tid
Intervention: High dose Xiang Ju Ru Pi Ning capsule (Drug)
Lower dose group
xiangjurupining capsule, 4 capsules,tid, xiangjurupining capsule placebo ,4 capsules，tid，po
Intervention: Low dose Xiang Ju Ru Pi Ning capsule (Drug)
Placebo group
xiangjurupining capsule placebo ,8 capsules，tid，po
Intervention: Xiang Ju Ru Pi Ning capsule placebo (Drug)
Outcomes
Primary Outcomes
The target lump
Time Frame: 3 months after treatment
Assess the scope ,the size and the hardness of the target lump by palpation.The doctor palpated the breast of the subjects and measured the size of the target lump with a ruler.Four quadrant method was used to record the number of the target lump's quadrants.Four level（0,2,4,6） to measure The scope,the size and the hardness of lump .the Score from 0(none) to 6(most severe).
The target lump area
Time Frame: 3 months after treatment
Assess the breast glandular section thickness, breast duct width and nodules of the target lump area by B-ultrasound.
The pain of breast
Time Frame: up to 3 months
Subject reported breast pain using NRS( Numerical Rating Scale)scale on the subject daily diary..The NRS scale is a line composed of 11 points, marked with a scale of 0 to 10. The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
The days of pain
Time Frame: up to 3 months
Subject reported breast pain as measured using NRS scale on the subject daily diary.The number of the pain days was calculated and compared with the baseline which the number of pain days in the lead-in period.
TCM syndrome scores
Time Frame: 3 months after treatment
Compared wth baseline,the scores of changes of TCM syndrome Evaluation at each visit .This instrument consists of two primary symptoms: breast pain, breast mass ,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3）, respectively. Record the tongue and pulse conditions. The TCM syndrome effect calculated by nimodipine method. The final score has a range of 0 to 100. The effect of TCM syndrome from 0% (negative ) to 100% (disappear).
Secondary Outcomes
No secondary outcomes reported