Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2022-06-13
Brief Title:
Efficacy of a Herbal Formula for Bone Metastases
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
RATIONALE Nearly 50 of patients with bone metastases develop one or more complications collectively termed skeletal-related events SREs The study herbal medicine might reduce the morbidities due to Skeletal-related events SRES and extend survival time
PURPOSE the study is to explore the effects of the 4 Herbs Formula on the reduction of Skeletal-related events SRES and survival time
PURPOSE the study is to explore the effects of the 4 Herbs Formula on the reduction of Skeletal-related events SRES and survival time
Detailed Description:
OBJECTIVES
Primary Primary efficacy end points are SRE general state and biomarkers Secondary Survival rate and survival time Time to first SRE since randomization Biochemical markers Quality of Life EQ5-D Pain control Brief Pain Inventory
OUTLINE
Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed
Primary Primary efficacy end points are SRE general state and biomarkers Secondary Survival rate and survival time Time to first SRE since randomization Biochemical markers Quality of Life EQ5-D Pain control Brief Pain Inventory
OUTLINE
Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed
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?:
None