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Clinical study of Jianpi Huayu Recipe in reducing blood hypercoagulability of advanced gastric cancer mediated by tissue factor

Clinical study of Jianpi Huayu Recipe in reducing blood hypercoagulability of advanced gastric cancer mediated by tissue factor

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003513
Enrollment
Unknown
Registered
2020-07-25
Start date
2020-07-20
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

gastric cancer

Interventions

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patients with pathological diagnosis of Gastric cancer; 2. The TNM stage was III-IV; 3. Patients with dysfunction of blood coagulation and meet the two following criteria: (1) PT shortening > 3s; (2) APTT shortening > 3s; (3) FIB > 4g/L; 4.DD > 0.5mg/l; 5.PLT > 300 * 10^9 / L; 4. Patients with criteria of TCM syndrome of blood stasis and weakened spleen and stomach; 5. Patients aged from 18 to 80 years old; 6. KPS score > 50; 7. Patients with life expectancy of at least 3 months; 8. No hemostasis, thrombolysis, anticoagulation, antiplatelet, non steroidal anti-inflammatory drugs or traditional Chinese medicine which effected of promoting blood circulation has been taken in the two weeks before admission; 9. Patients who provide written informed consent to participate in the study according to the GCP criteria.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients who is unable to swallow oral medications including with digestive tract obstruction and jejunostomy; 2. Patients with symptomatic brain metastasis or mental disorder; 3. Patients with severe cardiovascular disease, chronic liver disease, kidney disease or blood disease; 4. Patients with active bleeding (massive bleeding) or bleeding tendency; 5. Patients with serious uncontrolled medical diseases or acute infection; 6. Patients whose laboratory examination before enrollment is abnormal according to the following criteria: Blood routine examination: ANC 1.5 * upper normal limit (UNL); CCr 1.5 * UNL, ALT(SGPT) and AST (SGOT) > 1.5 * UNL; 7. Patients who are pregnant, nursing; 8. Patients who are substance abuse, or with clinical, mental, and social features which is interference for the study and informed consent.

Design outcomes

Primary

MeasureTime frame
inflammatory factors(IL-1ß\IL-8\IL-10\TNF-a\GM-CSF);VEGF;Tissue Factor;

Secondary

MeasureTime frame
platelet aggregation test with turbidimetry;Seven Items of Blood Coagulation;Karnofsky;complete blood count;

Countries

China

Contacts

Public ContactLing Bofan

Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine

407917536@qq.com+86 13770846676

Outcome results

None listed

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