Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

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

Sponsors

Lead Sponsor: Shandong University

Source Shandong University
Brief Summary

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

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.

Overall Status Recruiting
Start Date June 25, 2019
Completion Date April 1, 2020
Primary Completion Date April 1, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Sustained response to ITP treatments 3 months after treatment started
Secondary Outcome
Measure Time Frame
Evaluation of platelet response 3 months after treatment started
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Glycyrrhetinic Acid

Description: Compound glycyrrhizin tablets 75 mg three times per day, 1 month

Arm Group Label: glycyrrhetinic acid Combining HD-DXM

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: HD-DXM (orally at 40 mg daily for 4d)

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Hou, MD,PhD Principal Investigator Shandong University, Qilu Hospital
Overall Contact

Last Name: Ming Hou, MD,PhD

Phone: +86-531-82169114 Ext. 9879

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Qilu hospital, Shandong University Ming Hou [email protected] Ming Hou Principal Investigator
Location Countries

China

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor and Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: glycyrrhetinic acid Combining HD-DXM

Type: Active Comparator

Description: Compound glycyrrhizin tablets 75mg three times per day, 1 month, and HD-DXM (orally at 40 mg daily for 4d )

Label: HD-DXM

Type: Active Comparator

Description: HD-DXM (orally at 40 mg daily for 4d )

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov