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Corticosteroid

diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone for Thrombocytopenic Purpura

Phase 2
Waitlist Available
Led By Ming Hou, MD,PhD
Research Sponsored by Shandong University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year
Awards & highlights

Study Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Eligible Conditions
  • Thrombocytopenic Purpura

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
14-day initial overall response to ITP treatments
6-month sustained overall response to ITP treatments
Secondary outcome measures
duration of response
therapy associated adverse events
time to response

Trial Design

2Treatment groups
Active Control
Group I: diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasoneActive Control2 Interventions
Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
Group II: High-dose dexamethasoneActive Control1 Intervention
Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.

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Who is running the clinical trial?

Shandong UniversityLead Sponsor
286 Previous Clinical Trials
40,656,729 Total Patients Enrolled
Ming Hou, MD,PhDPrincipal InvestigatorShandong University Qilu Hospital
2 Previous Clinical Trials
70 Total Patients Enrolled
~28 spots leftby Jun 2025
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