Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT04229706
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)
Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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。
Patients report their breast pain as measured using NRS scale on the subject daily diary。
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: