NCT02556814

Caffeic Acid Combining High-dose Dexamethasone in Management of ITP

A Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 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 caffeic acid tablets combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Detailed description

The investigators are undertaking a multicenter, randomized, double blinded placebo-controlled trial of 240 primary ITP adult patients from 8 medical centers in China. One part of the participants are randomly selected to receive caffeic acid tablets (given orally at a dose of 900mg per day for 3 consecutive months), 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 caffeic acid tablets combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Caffeic acid tablets	Oral administration of caffeic acid tablets 0.3g three times per day for 3 months
DRUG	Dexamethasone	Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later.
DRUG	placebo	Oral administration of placebo tablets 0.3g three times per day for 3 months

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-01
• Completion: 2018-10-01
• First posted: 2015-09-22
• Last updated: 2020-03-20

Locations

1 site across 1 country: China