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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caffeic acid tablet and dexamethasone | Experimental | Oral administration of caffeic acid tablets 0.3g three times per day for 3 months. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later. |
|
| Placebo and dexamethasone | Active Comparator | Oral administration of placebo tablets 0.3g three times per day for 3 months. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeic acid tablets | Drug | Oral administration of caffeic acid tablets 0.3g three times per day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| sustained response to ITP treatments | percentage of patients maintaining PLT count over 30*10^9 without bleeding | 6 months after treatment started |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of platelet response | Complete response (CR): A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding. 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. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming Hou, MD, PhD | Shandong University Qilu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital, Shandong University | Jinan | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40846660 | Derived | Wang R, Liu Y, Wang R, Cao J, Hao Y, Xiao T, Yu Z, Yu W, Chu X, Ran X, Zhu C, Xu R, Xiao J, Deng X, Zhang H, Wang Z, Liu G, Hou M, Hou Y. Caffeic acid tablets plus high-dose dexamethasone versus placebo plus high-dose dexamethasone in patients with newly diagnosed immune thrombocytopenia: A multicenter, double-blind, randomized, controlled, phase 2 trial. Chin Med J (Engl). 2025 Aug 22. doi: 10.1097/CM9.0000000000003783. Online ahead of print. |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C040048 | caffeic acid |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug | Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later. |
|
| placebo | Drug | Oral administration of placebo tablets 0.3g three times per day for 3 months |
|
| 3 months after treatment started |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |