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Clinical Efficacy and Safety of Integrated Mongolian and Western Medicine in the Treatment of Immune Thrombocytopenia: Protocol of a Randomized Controlled Clinical Trial

Project for Enhancing Evidence-Based Capacity of Integrated Mongolian and Western Medicine in the Treatment of Immune Thrombocytopenia?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000112
Enrollment
Unknown
Registered
2026-01-17
Start date
2023-07-15
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Immune Thrombocytopenia

Interventions

Intervention Group:Conventional treatment + Tonglaga 601
Patients in the experimental group receive the intervention of combined conventional treatment and Tonglaga 601. The conventional treatment regimen is: Initially give an intravenous drip of dexamethas
Control Group:Conventional treatment + Simulant of Tonglaga-601
Patients in the control group receive the intervention of combined conventional treatment and the simulant of Tonglaga 601. The conventional treatment regimen is: Initially give an intravenous drip of

Sponsors

Inner Mongolia International Mongolian Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed Western medical diagnosis of immune thrombocytopenia (ITP), with a platelet (PLT) count < 30×109/L or presence of bleeding symptoms. 2. Adult patients aged 18 to 75 years. 3. Patients who used immunosuppressants such as Cyclosporine A, Vincristine, and Azathioprine prior to consultation may be included after completing a washout period (Cyclosporine A: 10-16 hours; Vincristine: 27 hours; Azathioprine: 5-10 hours). 4. Patients who provide informed consent, voluntarily participate in the study, and commit to taking medications 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 effective rate of platelets;Bleeding Score Scale;

Secondary

MeasureTime frame
Platelet Count;Fatigue Scoring Table;

Countries

China

Contacts

Public ContactChen shana

Inner Mongolia International Mongolian Medical Hospital

Chenshana@126.com13948129872

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026