Corticosteroid-resistant or Relapsed ITP

Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks

Berberine plus danazol

Peking University Institute of Hematology

Combination of Danazole With Berberine in the Treatment of ITP

12-month sustained response defined as platelet count of 30×10⁹/L or more and at least a doubling of baseline platelet count (partial response (PR)), or a platelet count of 100×10⁹/L or more and the absence of bleeding without rescue medication(complete response (CR))

adverse event/serious adverse event associated with study drugs and cumulative rate of bleeding

Xiao Hui Zhang

Prof.

Peking University People's Hospital

In the Berberine Arm, patients will receive berberine 200 mg twice daily for 4±1 weeks (Stage 1); then, 300 mg twice daily for 4±1 weeks (Stage 2); then, 400 mg twice daily for 4±1 weeks (Stage 3) in addition to standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.

In the Control Arm, patients will receive standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.

Coronary Artery Disease

Percutaneous Coronary Intervention

Berberine 200 mg twice daily for 4±1 weeks (Stage 1); then, 300 mg twice daily for 4±1 weeks (Stage 2); then, 400 mg twice daily for 4 weeks (Stage 3).

Berberine

Standard treatment

Aspirin 100 mg once daily for 12±1 weeks.

Aspirin

Clopidogrel 75 mg once daily for 12±1 weeks.

Clopidogrel

Peking Union Medical College Hospital

Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention

A Single-center, Randomized, Open-label, Controlled, Dose-escalating, Parallel-group Study to Assess the Anti-platelet Effect of Berberine in Patients Receiving Aspirin and Clopidogrel After Percutaneous Coronary Intervention

The P2Y12 reaction unit (PRU) assessed by VerifyNow assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT), i.e., on the 12th (11th-13th) week of treatment

The P2Y12 reaction unit (PRU) assessed by VerifyNow assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of Stage 2 (Visit 3) [ i.e., on the 8th (7th-9th) week of treatment ]

The P2Y12 reaction unit (PRU) assessed by VerifyNow assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of Stage 1 (Visit 2) [ i.e., on the 4th (3rd-5th) week of treatment ]

The platelet reactivity index (PRI) assessed by vasodilator-stimulated phosphoprotein-phosphorylation (VASP-P) assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT) [ i.e., on the 12th (11th-13th) week of treatment ]

The platelet reactivity index (PRI) assessed by vasodilator-stimulated phosphoprotein-phosphorylation (VASP-P) assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of Stage 2 (Visit 3) [ i.e., on the 8th (7th-9th) week of treatment ]

The platelet reactivity index (PRI) assessed by vasodilator-stimulated phosphoprotein-phosphorylation (VASP-P) assay 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of Stage 1 (Visit 2) [ i.e., on the 4th (3rd-5th) week of treatment ]

The urinary 11-dehydro-thromboxane B2 (11-dH-TXB2) assessed by enzyme-linked immunosorbent assay (ELISA) 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT) [ i.e., on the 12th (11th-13th) week of treatment ]

The urinary 11-dehydro-thromboxane B2 (11-dH-TXB2) assessed by enzyme-linked immunosorbent assay (ELISA) 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of Stage 2 (Visit 3) [ i.e., on the 8th (7th-9th) week of treatment ]

The urinary 11-dehydro-thromboxane B2 (11-dH-TXB2) assessed by enzyme-linked immunosorbent assay (ELISA) 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of Stage 1 (Visit 2) [ i.e., on the 4th (3rd-5th) week of treatment ]

The composite of death, or myocardial infarction, or urgent coronary revascularization, or definite or possible stent thrombosis, up to the end of the treatment period (Visit 4, EOT), i.e., the 12th (11th-13th) week of treatment

The major bleeding according to platelet inhibition and patient outcomes (PLATO) definition up to the end of the treatment period (Visit 4, EOT), i.e., the 12th (11th-13th) week of treatment

The minor bleeding according to platelet inhibition and patient outcomes (PLATO) definition up to the end of the treatment period (Visit 4, EOT), i.e., the 12th (11th-13th) week of treatment

The minimal bleeding according to platelet inhibition and patient outcomes (PLATO) definition up to the end of the treatment period (Visit 4, EOT), i.e., the 12th (11th-13th) week of treatment

The major or minor bleeding according to platelet inhibition and patient outcomes (PLATO) definition up to the end of the treatment period (Visit 4, EOT), i.e., the 12th (11th-13th) week of treatment

The major or minor or minimal bleeding according to platelet inhibition and patient outcomes (PLATO) definition up to the end of the treatment period (Visit 4, EOT), i.e., the 12th (11th-13th) week of treatment

The P-selectin (CD62p) expression assessed by flow cytometry 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT) [ i.e., the 12th (11th-13th) week of treatment ]

Serum soluble P-selectin (sCD62p) assessed by enzyme-linked immunosorbent assay (ELISA) 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT) [ i.e., on the 12th (11th-13th) week of treatment ]

Serum soluble CD40 ligand (sCD40L) assessed by enzyme-linked immunosorbent assay (ELISA) 2-4 h after all the antiplatelet agents are taken simultaneously in the morning at the end of the treatment period (Visit 4, EOT) [ i.e., on the 12th (11th-13th) week of treatment ]

LiuZhenyu

Professor

On the first day of the treatment period (Visit 1), eligible patients will be randomized into the Berberine Arm and the Control Arm.
In the Berberine Arm, patients will receive berberine 200 mg twice daily for 4±1 weeks (Stage 1); then, 300 mg twice daily for 4±1 weeks (Stage 2); then, 400 mg twice daily for 4±1 weeks (Stage 3) in addition to standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.
In the Control Arm, patients will receive standard treatment, including aspirin 100 mg once daily and clopidogrel 75 mg once daily for 12±1 weeks.

berberine/hemorrhage

Combination of Danazole With Berberine in the Treatment of ITP

Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention

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