NCT04229706

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	High dose Xiang Ju Ru Pi Ning capsule	xingjurupining capsule,8 capsule,tid,3 months.
DRUG	Low dose Xiang Ju Ru Pi Ning capsule	xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months.
DRUG	Xiang Ju Ru Pi Ning capsule placebo	xiangjurupining capsule,8 capsule,tid,3 months.

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-01-12
• Completion: 2022-01-15
• First posted: 2020-01-18
• Last updated: 2024-09-05

Locations

8 sites across 1 country: China