Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

Study Overview
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Brief Summary
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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 glycyrrhetinic acid combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Detailed Description
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The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients. One part of the participants are randomly selected to receive glycyrrhetinic acid (given compound glycyrrhizin tablets orally at a dose of 225mg per day for 1 month), 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 glycyrrhetinic acid combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Official Title
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A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Glycyrrhetinic Acid
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia; Untreated hospitalized patients, may be male or female, between the ages of 18  80 years; To show a platelet count <30 * 10^9/L, and with bleeding manifestations; Willing and able to sign written informed consent Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study; Current HIV infection; Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test; Patients who are deemed unsuitable for the study by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glycyrrhetinic acid Combining HD-DXM<br>Compound glycyrrhizin tablets 75mg three times per day, 1 month, and HD-DXM (orally at 40 mg daily for 4d ) | Drug: Glycyrrhetinic Acid<br>* Compound glycyrrhizin tablets 75 mg three times per day, 1 month<br>Drug: Dexamethasone<br>* HD-DXM (orally at 40 mg daily for 4d)<br>|
| Active Comparator: HD-DXM<br>HD-DXM (orally at 40 mg daily for 4d ) | Drug: Dexamethasone<br>* HD-DXM (orally at 40 mg daily for 4d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained response to ITP treatments | Percentage of patients maintaining PLT count over 30*10^9 without bleeding | 3 months after treatment started | 

Secondary Outcome Measures

| Outcome Measure | 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. | 3 months after treatment started | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITP；glycyrrhetinic acid；dexamethasone