Recent Updates
Recently added Catalysts

xue-fu-zhu-yu

Phase 2

Qi Stagnation and Blood Stasis Syndrome | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Nov 26, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03091634The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treatment of Qi Stagnation and Blood Stasis Syndrome.PHASE2 COMPLETED 120May 6, 2017Dec 31, 2018Nov 26, 20193 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The Traditional Chinese Medicine PRO Scale
baseline, 2nd,4th,6th and 7th week

The Traditional Chinese Medicine PRO scale includes physiological domain,psychological domain,independence and social domain. And the change of the total score of the Traditional Chinese Medicine PRO Scale in Patients of QS\&BSS will be assessed.

Secondary Endpoints
The single symptom and sign scale of QS&BSS
baseline, 2nd,4th,6th and 7th week
The pain scale of QS&BSS
baseline, 2nd,4th,6th and 7th week
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
test groupEXPERIMENTALthe patients in this group take 6 xue-fu-zhu-yu capsules once, twice a day, for 7weeks.
control groupPLACEBO_COMPARATORthe patients in this group take 6 xue-fu-zhu-yu capsule simulated agents once, twice a day, for 7weeks..
Interventions
NameTypeDescription
xue-fu-zhu-yu capsuleDRUGparticipants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks
xue-fu-zhu-yu capsule simulated agentDRUGparticipants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * The participants diagnosed as QS\&BSS; * The age of participants is from 18 to 65; * Participants who voluntarily signed informed consent. Exclusion Criteria: * Participants with other obvious Chinese medicine syndrome * Participants diagnosed as acute myocardiac infarction,...

Countries:China
Unlock Eligibility Criteria