NCT02351622

Caffeic Acid Tablets as a Second-line Therapy for ITP

A Multicentre Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Detailed description

All participants' platelet count will be monitored weekly. Response will be evaluated after 3, 6 and 12 months after treatment. If the participant did not get complete response or response after 3 months, he would quit the trail.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Caffeic acid	Oral administration of caffeic acid tablet 0.3g three times per day for 1 year
DRUG	Dexamethasone	Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
DRUG	Placebo	Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-01-30
• Last updated: 2016-04-20

Locations

1 site across 1 country: China