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NCT Number: NCT07200921

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills

This study aims to evaluate the effectiveness and safety of a Chinese medicine-based intervention combined with standard medicine, in reducing composite vascular events in patients with hypertensive intracerebral hemorrhage (HICH).This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 1950 participants with HICH within 7 days of onset, accompanied by imaging evidence of cerebral small vessel disease, will be enrolled.Participants will be randomly assigned to receive eitherNaoxuekang Dropping Pills or matching placebo for 90 days, in addition to guideline-based standard care.The primary outcome is the incidence of composite vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death, deep vein thrombosis, and pulmonary embolism) within 1 year.Secondary outcomes include vascular events within 90 days, neurological function (mRS), and cognitive function (MMSE, MoCA) at 90 days and 1 year.Safety will be monitored through adverse event reporting.The results will provide evidence for optimizing secondary prevention strategies in HICH patients.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location contact

Qian Zhang, MD

CONTACT

[email protected]

+86-010-5997-8585

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets the diagnostic criteria for hypertensive intracerebral hemorrhage.
  • Able to cooperate with a head MRI examination and has imaging manifestations of cerebral small vessel disease (CSVD) (Staals total CSVD burden score ≥ 1).
  • Supratentorial hemorrhage (volume ≤ 30ml) or infratentorial hemorrhage (volume ≤ 10ml).
  • Within 7 days of symptom onset.
  • NIHSS score ≤ 25.
  • GCS score ≥ 8.
  • Age between 18 and 80 years (inclusive).
  • Any gender

Exclusion criteria

  • Primary intraventricular hemorrhage.
  • Spontaneous intracerebral hemorrhage due to other causes or secondary intracerebral hemorrhage (e.g., from trauma, vascular malformations, coagulation disorders, hematological diseases, systemic diseases, or tumors).
  • Planned surgical intervention (including craniotomy for hematoma evacuation, minimally invasive hematoma removal, or ventricular puncture).
  • Patients with active peptic ulcer, bleeding, or other clear tendency for rebleeding.
  • Patients with severe hepatic or renal dysfunction (Severe hepatic dysfunction: ALT or AST > 3 times the upper limit of normal; Severe renal dysfunction: Serum creatinine > 2 times the upper limit of normal).
  • Suffering from other life-threatening severe diseases with an expected survival time of less than 1 year.
  • Known allergy to any component of the study drug.
  • Pregnant women, women planning pregnancy, or lactating women.
  • Participating in another interventional clinical trial.

Treatment and study plan

Naoxuekang Dropping Pills

Drug

A traditional Chinese medicine. Each pill weighs 35mg. Dosage: 20 pills, three times daily, orally for 90 days.

Naoxuekang Matching Placebo

Drug

A placebo pill matched to Naoxuekang Dropping Pills in appearance, taste , size, and packaging. Dosage: 20 pills, three times daily, orally for 90 days.

Primary outcomes

  1. Incidence of Composite Vascular Events

    Time frame: Within 1 year after the onset of intracerebral hemorrhage.

    Composite vascular events within one year of onset, including arterial vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death) and venous vascular events (lower extremity venous thrombosis, pulmonary embolism).

Study contacts

Contact information is provided by the study sponsor or research team.

Xintong Song, MD

CONTACT

[email protected]

010-17519241291

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Kangerfu Pharmaceutical Company Limited
  • The Affiliated Hospital of Qingdao University

Registry information

Acronym: TCM-ICH

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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