NCT03998982

Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients. One part of the participants are randomly selected to receive glycyrrhetinic acid (given compound glycyrrhizin tablets orally at a dose of 225mg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of glycyrrhetinic acid combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Glycyrrhetinic Acid	Compound glycyrrhizin tablets 75 mg three times per day, 1 month
DRUG	Dexamethasone	HD-DXM (orally at 40 mg daily for 4d)

Timeline

• Start date: 2019-06-25
• Primary completion: 2021-06-10
• Completion: 2021-06-10
• First posted: 2019-06-26
• Last updated: 2021-06-11

Locations

1 site across 1 country: China