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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Oral administration of caffeic acid tablet 0.3g three times per day for 1 year
Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.
Shandong University Qilu hospital
Jinan, Shandong, China
Proposed criteria for assessing response to ITP treatments
1. Complete response (CR): A platelet count ≥ 100 \* 10\^9/L measured on two occasions \> 7 days apart and the absence of bleeding. 2. Response (R): A platelet count ≥ 30 \* 10\^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions \> 7 days apart and the absence of bleeding. 3. No response (NR): A platelet count \< 30 \* 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. 4. Relapses: platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.
Time frame: 3 months after treatment started
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