Clinical study of Zhishen Yuanhu anticoagulant formula in prevention of venous thromboembolism in malignant tumor: a multicenter prospective randomized controlled clinical trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000004029

Enrollment

Unknown

Registered

2020-10-22

Start date

2021-01-01

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

venous thromboembolism in malignant tumor

Interventions

trial group:Zhishen Yuanhu anticoagulant formula

control group:low molecular weight heparin sodium injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Aged > 18 years; (2) There is no contraindication to anticoagulation therapy, and the expected survival is greater than 6 months. (3) Malignant tumors that occur in the pancreas, ovary, brain, stomach, gynecology, colon, lung, and hematology, and patients who have undergone surgery, radiotherapy and chemotherapy, or whose tumors are in advanced, advanced, and cachexia; (4) Normal coagulation function: PT 1216s, INR 0.81.5, APTT2436s, FIB24g/L; (5) Creatinine clearance rate> 20 ml/min; (6) Khorana scores are middle-high risk patients; (see appendix for Khorana scoring criteria); (7) Doppler ultrasonography before operation has no DVT; (8) The patient expressed informed consent and signed an informed consent form; (9) The test group ( Zhishen Yuanhu anticoagulant formula group) additional inclusion criteria: spleen and kidney yang deficiency, blood stasis type.

Exclusion criteria

Exclusion criteria: (1) Known allergy to low molecular weight heparin sodium, leech, Yuanhu or Codonopsis; (2) Those with severe vascular sclerosis; (3) Those suffering from phlebitis of the lower extremities; (4) Patients with lower limb edema or pulmonary edema caused by congestive heart failure; (5) People with recent coagulation dysfunction or active bleeding from important organs; (6) Those with open wounds or skin infections on the skin of the lower limbs; (7) The test group (Zhishen Yuanhu anticoagulant formula group) additional exclusion criteria: damp-heat type (corresponding to thrombosis, acute phase), heterologous protein allergy, yellow and thick tongue coating.

Design outcomes

Primary

Measure	Time frame
Serum Hcy and P-selection;Coagulation index;Hemorheology Index;Deep venous thrombosis;	—

Secondary

Measure	Time frame
Lower limb circumference;Tongue coating;	—

Countries

China

Contacts

Public ContactYang Hongru

Luzhou People's Hospital

343922738@qq.com+86 18583068203

Outcome results

None listed

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