A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)

NCT ID: NCT04229706

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2022-01-15

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。

Conditions

Hyperplasia of Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High dose group

xiangjurupining capsule ,8 capsules，tid

Group Type: EXPERIMENTAL

High dose Xiang Ju Ru Pi Ning capsule

Intervention Type: DRUG

xingjurupining capsule,8 capsule,tid,3 months.

Lower dose group

xiangjurupining capsule, 4 capsules,tid, xiangjurupining capsule placebo ,4 capsules，tid，po

Group Type: EXPERIMENTAL

Low dose Xiang Ju Ru Pi Ning capsule

Intervention Type: DRUG

xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months.

Placebo group

xiangjurupining capsule placebo ,8 capsules，tid，po

Group Type: PLACEBO_COMPARATOR

Xiang Ju Ru Pi Ning capsule placebo

Intervention Type: DRUG

xiangjurupining capsule,8 capsule,tid,3 months.

Interventions

High dose Xiang Ju Ru Pi Ning capsule

xingjurupining capsule,8 capsule,tid,3 months.

Intervention Type: DRUG

Low dose Xiang Ju Ru Pi Ning capsule

xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months.

Intervention Type: DRUG

Xiang Ju Ru Pi Ning capsule placebo

xiangjurupining capsule,8 capsule,tid,3 months.

Intervention Type: DRUG

Other Intervention Names

High dose group; Low dose group; Placebo group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baoding No.1 Hospital of TCM

Baoding, , China

Dongfang Hospital ,Beijing University of Chinese Medicine

Beijing, , China

Dongzhimen Hospital,Beijing University of Chinese Medicine

Beijing, , China

Guangdong Provincial Hospital of TCM

Guangzhou, , China

the First Affiliated Hospital of Guangzhou University of TCM

Guangzhou, , China

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, , China

SHUGUANG Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Weifang Traditional Chinese Hospital

Weifang, , China

Countries

China

Other Identifiers

TSL-TCM-XJRPNJN-Ⅱ

Identifier Type: -

Identifier Source: org_study_id