Clinical TrialID 6613
Caffeic Acid Tablets as a Second-line Therapy for ITP
NCT02351622
Immune Thrombocytopenia
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6613
- Evidence Id
- 6613
- Core Evidence Id
- 6613
- Source Clinical Trial Id
- 6600
- Herb2 Clinical Trial Id
- HBCT006600
- Nct Id
- NCT02351622
- Title
- Caffeic Acid Tablets as a Second-line Therapy for ITP
- Status
- Completed
- Phase
- Phase 3
- Study Result
- No
- Study Condition
- Immune Thrombocytopenia
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Caffeic acid|DRUG: Dexamethasone|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 103
- Outcome Measure
- 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., 3 months after treatment started
- Sponsor Collaborator
- Shandong University|Shandong Provincial Hospital|Qianfoshan Hospital|Anhui Medical University|Qingdao University
- Funded By
- OTHER
- Location
- Shandong University Qilu hospital, Jinan, Shandong, 250012, China
- Other Id
- ITP-Caffeic acid
- Start Date
- 2012-09
- Primary Completion Date
- 2013-12
- Completion Date
- 2013-12
- First Posted
- 2015-01-30
- Results First Posted
- Last Update Posted
- 2016-04-20
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02351622
- Title Cn
- Title En
- Caffeic Acid Tablets as a Second-line Therapy for ITP
- Bilingual Status
- semi_complete