FindTrial
Sign In

A Randomized, Double-Blind, Placebo-Controlled Study of the Combination of Spleen-Invigorating Kidney-Nourishing Fire-Purging Formula and TPO-RA for the Treatment of Primary Immune Thrombocytopenia After First-Line Treatment Failure

A Randomized, Double-Blind, Placebo-Controlled Study of the Combination of Spleen-Invigorating Kidney-Nourishing Fire-Purging Formula and TPO-RA for the Treatment of Primary Immune Thrombocytopenia After First-Line Treatment Failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086350
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia

Interventions

Control group:TPO-RA (avatrombopag dose of 5 mg, orally once daily) + Placebo (As the placebo needs to be identical to the tested Chinese medicine in appearance, color, smell, taste, packaging, usage,
Experimental group:TPO-RA (avatrombopag dose of 5 mg, orally once daily) + Spleen-tonifying, Kidney-nourishing, and Fire-purging Formula (Composition of the Spleen-tonifying, Kidney-nourishing, and Fi

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the Western medical diagnostic criteria for ITP, with a disease duration of more than 3 months and who are either dependent on or unresponsive to glucocorticoids (i.e., patients who have failed first-line treatment for ITP); (2) Patients who meet the Traditional Chinese Medicine diagnostic criteria for ITP with spleen-kidney yin deficiency and fire-heat damaging the collaterals syndrome; (3) Age between 18-70 years old, regardless of gender; (4) No use of immunosuppressants, TPO-RA, or similar drugs within 1 month prior to enrollment; (5) Willing to accept this treatment plan and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe organic diseases such as heart, brain, liver, or kidney failure, as well as those with other malignant tumors or psychiatric disorders; (2) Patients with any significant abnormal comorbidities or extremely poor nutritional status that may affect the patient's life safety or compliance; (3) Individuals allergic to any of the drugs involved in the treatment regimen; (4) Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Platelet count;Total dose of avatrombopag;Six-item cellular immunity test +Five-item anti-platelet antibody test; absolute count ; Five-item anti-platelet antibody test;—

Secondary

MeasureTime frame
Bleeding score;Traditional Chinese Medicine syndrome score;Seven coagulation tests , Thromboelastography (TEG) test;Three-location deep vein thrombosis (DVT) screening;—

Countries

China

Contacts

Public ContactBao Jizhang

Shanghai Municipal Hospital of Traditional Chinese Medicine

xyzsbjz@126.com+86 137 6418 2916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026