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The Application Value of Traditional Chinese Medicine Intervention in Blood Resource Shortage Periods: A Randomized Controlled Study on the Reduction of Transfusion Rate in Orthopedic Surgery Patients with Traumatic Injuries Using Shengyu Decoction

The Application Value of Traditional Chinese Medicine Intervention in Blood Resource Shortage Periods: A Randomized Controlled Study on the Reduction of Transfusion Rate in Orthopedic Surgery Patients with Traumatic Injuries Using Shengyu Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001803
Enrollment
Unknown
Registered
2025-09-21
Start date
2025-09-28
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

anemia

Interventions

Shengyu Decoction group:oral Shengyu decoction and usual care
Control group:usual care

Sponsors

Yizhang County Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Aged 18–75 years, either sex; 2) Diagnosed with a limb, pelvic or hip fracture that requires surgical treatment; 3) Scheduled to undergo internal fixation or joint replacement; 4) American Society of Anesthesiologists (ASA) physical status I–III; 5) Anticipated intra-operative blood loss likely to necessitate post-operative transfusion (judged from pre-operative evaluation and procedure type, e.g. expected loss > 500 mL or specific high-risk surgery); 6) Pre-operative haemoglobin: males = 90 g/L and < 130 g/L, females = 90 g/L and < 120 g/L; 7) Able to understand and comply with the protocol, take medication on time and attend follow-up visits; 8) Patient and family members have been fully informed and have voluntarily signed the written informed-consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1) Known hypersensitivity to any component of Shengyu Decoction; 2) Pregnant or lactating women; 3) Severe cardiac, hepatic, or renal insufficiency; 4) Co-existing coagulation disorders or long-term use of anticoagulant drugs; 5) Concurrent malignant tumor or hematological disease; 6) Open fracture classified as Gustilo type III; 7) Polytrauma with ISS > 16, or unstable vital signs requiring emergency transfusion; 8) Pre-existing severe anaemia (Hb < 90 g/L for both sexes) for which pre-operative transfusion is already planned; 9) Participation in another clinical trial; 10) Any other condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
transfusion rate within 7 days after surgery;

Secondary

MeasureTime frame
complete blood count (CBC);blood loss;drain output;inflammatory markers;coagulation parameters;

Countries

China

Contacts

Public ContactNanshan Wu

Yizhang County Hospital of Traditional Chinese Medicine

wunanshan2024@163.com15096164730

Outcome results

None listed

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