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Chang'an I Recipe

Phase 1

Irritable Bowel Syndrome With Diarrhea | Small molecule | Gastrointestinal |China Pharma Holdings, Inc.|Last Updated: Sep 5, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment216
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02822118Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With DiarrheaPHASE1 COMPLETED 216Jan 1, 2013May 1, 2016Sep 5, 20165 China
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Study Endpoints
Primary Endpoints
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.

Score less than 75 points was considered as in remission, 75\~175 as mild, 175\~300 as moderate, and over 300 as severe.

Secondary Endpoints
Serum markers regarding liver and kidney function
at baseline and 8 weeks.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chang'an I RecipeEXPERIMENTALPatients in this group were administered the Chang'an I Recipe for 8 weeks.
PlaceboPLACEBO_COMPARATORPatients in this group were administered the placebo for 8 weeks.
Interventions
NameTypeDescription
Chang'an I RecipeDRUGPatients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
PlaceboDRUGPatients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients meeting the diagnostic criteria of Western medicine for IBS-D; * aged 18-70 years old; with a baseline IBS-SSS score over 75 points; * voluntarily signed the informed consent; * local resident who could ensure follow-ups, with basic reading ability. Exclusion Criteri...

Countries:China
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