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The improved evidence-based capabilities project for treatment of immune thrombocytopenia with the combination of Mongolian and Western medicine

The improved evidence-based capabilities project for treatment of immune thrombocytopenia with the combination of Mongolian and Western medicine

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074376
Enrollment
Unknown
Registered
2023-08-04
Start date
2023-07-25
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

Immune Thrombocytopenia

Interventions

Treatment group:Basic treatment+dexamethasone injection+Mongolian medicine 1. Dexamethasone injection, medication method: 40mg intravenous drip once a day for four consecutive days 2. Mongolian medici
Tonglaga-601, 13-15 pills, taken orally after lunch
Babu-7, 13-15 pills, taken orally after meals at night. (2) Type of excessive Badagan-Heyi:Five clear-turbid pill, 13-15 pills, taken orally on an empty stomach in the morning
Amibargeqi-18, 13-15 pills, taken orally after dinner.
Control group:Mongolian medicine Tonglaga 601 simulation agent, which has the same color, odor, and appearance as Tonglaga 601, but does not contain any active ingredients. It is provided by the Natio

Sponsors

Inner Mongolia International Mongolian Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Clear diagnosis of ITP with platelet count (PLT)<30 × 109/L or with bleeding symptoms; (2) Adult patients aged 18-75; (3) Meets the diagnostic criteria for Mongolian medicine syndrome; (4) Patients who applied Immunosuppressive drug such as Ciclosporin A, Vincristine and Azathioprine before treatment can be included after the washout period (Ciclosporin A: 10-16 hours, Vincristine: 27 hours, Azathioprine: 5-10 hours); (5) The patient has informed consent, voluntarily participates, and insists on taking medication regularly.

Exclusion criteria

Exclusion criteria: (1) Patients who received high-dose glucocorticoid pulse therapy during the first 3 months before seeking medical attention; (2) Patients with severe immune deficiency; (3) Patients with severe heart, liver, and kidney dysfunction; (4) Patients who cannot accept or tolerate medication treatment; (5) Those who cannot use medication according to regulations, have poor compliance, cannot determine efficacy, or have incomplete information that affects efficacy and safety judgment; (6) Those who have received relevant treatment and may have an impact on the efficacy observation indicators.

Design outcomes

Primary

MeasureTime frame
The platelet count;Mongolian Medicine Syndrome Score;bleeding score;

Secondary

MeasureTime frame
T helper cell 17,Th17;Regulatory cells,Treg;Interleukin-17,IL-17;Interleukin-10,IL-10;Interleukin-9,IL-9;Interleukin-8,IL-8;Fatigue score;

Countries

China

Contacts

Public ContactShana Chen

Inner Mongolia International Mongolian Medical Hospital

chenshana@126.com+86 139 4812 9872

Outcome results

None listed

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