Efficacy and safety of Nao-Xue-Shu oral liquid in patients with intracranial hematoma after craniocerebral surgery: a randomized, open, controlled, multi-center clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800017981

Enrollment

Unknown

Registered

2018-08-25

Start date

2018-10-01

Completion date

Unknown

Last updated

2022-01-24

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

Conditions

intracranial hematoma after craniocerebral surgery

Interventions

Experimental group:Nao-Xue-Shu oral liquid

Control group:Blank

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Patients with intracranial hematoma after craniocerebral surgery; 3. 10ml= Supratentorial hematoma =30mlInfratentorial hematoma =10ml or Ventricle hematoma; 4. Provision of informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to the ingredients of this study drug; 2. Patients who need to undergo craniotomy hematoma evacuation; 3. Severe liver dysfunction or renal insufficiency: Alanine transaminase > 2 times normal upper limit or Aspartate aminotransferase > 2 times normal upper limit; serum creatinine > 1.5 times normal upper limit; 4. Systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg; 5. Patients who have a severe bleeding tendency or more likely to bleed again; 6. Patients who have been taking anticoagulant drugs within 3 months; 7. Patients who may be treated with unfractionated heparin or low molecular weight heparin during the trial; 8. Patients with a life expectancy of less than one month or patients or failed to follow the study for other reasons; 9. Pregnancy or lactation, and women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test; 10. Participate in clinical studies of other research drugs within the last 30 days; 11. Incapable to follow this study for mental illness, cognitive or emotional disorder; 12. Unsuitable for this study in the opinion of the investigators.

Design outcomes

Primary

Measure	Time frame
Proportion of hematoma volume;Severity Adverse Event;	—

Secondary

Measure	Time frame
Proportion of hematoma volume;Hematoma volume;Edema volume;Changes in NIHSS scores;Proportion of good functional outcome (mRS 0-2);Score of the Barthel Index;Glasgow Coma Scale;Glasgow Outcome Scale Extended (GOSE);Adverse Events;Total mortality;	—

Countries

China

Contacts

Public ContactDezhi Kang

Frist Affiliated Hospital of Fujian Medical University

kdz99988@sina.com+86 0591-87982127

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026