A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP

January 23, 2026 updated by: Ming Hou, Shandong University

High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Qilu Hospital, Shandong University
      • Qingdao, Shandong, China, 266000
        • Qilu hospital (Qingdao), Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for immune thrombocytopenia;
  • Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18~ 80 years;
  • To show a platelet count <30 * 10^9/L, or with bleeding manifestations, or both;
  • Willing and able to sign written informed consent
  • ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified.

Exclusion Criteria:

  • secondary thrombocytopenia;
  • severe immune-deficiency;
  • active or previous malignancy;
  • HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);
  • pregnancy or lactation;
  • diabetes;
  • hypertension;
  • cardiovascular diseases;
  • severe kidney function impairment;
  • psychosis;
  • osteoporosis;
  • inflammatory bowel disease or gastric disease;
  • arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment;
  • an organ or haematopoietic stem-cell transplantation;
  • neutrophil count of less than 1500 cells per mm³;
  • glycosylated haemoglobin less than 8%;
  • partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes;
  • history of primary immunodeficiency;
  • neoplastic disease within the past 5 years;
  • corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
  • substance misuse within the previous 12 months;
  • people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High-dose dexamethasone
Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
Drug: dexamethasone
40 mg qd for 4 days
Active Comparator: diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone
Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
Drug: dexamethasone
40 mg qd for 4 days
Drug: diammonium glycyrrhizinate enteric-coated capsule
150mg tid for 1 month

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
14-day initial overall response to ITP treatments
Time Frame: 14 days after treatment started
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
14 days after treatment started
6-month sustained overall response to ITP treatments
Time Frame: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
time to response
Time Frame: an average of 6 months
the time from treatment initiation to achieve a complete response or a partial response
an average of 6 months
duration of response
Time Frame: through study completion, an average of one year
the time from achievement of a complete response or a partial response to the loss of response (platelet count <30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).
through study completion, an average of one year
therapy associated adverse events
Time Frame: up to one year
nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ming Hou, MD,PhD, Shandong University Qilu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITP-Diammonium Glycyrrhizinate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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