Hypertensive Intracerebral HemorrhagePhase 2TCM-ICHNCT07200921
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills
A Phase 2 study testing Naoxuekang Dropping Pills in people with Hypertensive Intracerebral Hemorrhage and Cerebral Small Vessel Diseases, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertensive Intracerebral Hemorrhage, Cerebral Small Vessel Diseases
- What is being tested?
- Naoxuekang Dropping Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,950 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Known allergy to any component of the study drug.
- Pregnant women, women planning pregnancy, or lactating women.
- Participating in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Qian Zhang, MD, +86-010-5997-8585, goongchangqian@126.com
About this study
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.
- Being tested
- Naoxuekang Dropping Pills, Naoxuekang Matching Placebo
- Keywords
- Hypertensive intracerebral hemorrhage, Cerebral small vessel disease, Naoxuekang Dropping Pills, Randomized controlled trial
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naoxuekang Dropping PillsDrug
A traditional Chinese medicine. Each pill weighs 35mg. Dosage: 20 pills, three times daily, orally for 90 days.
Naoxuekang Matching PlaceboDrug
A placebo pill matched to Naoxuekang Dropping Pills in appearance, taste , size, and packaging. Dosage: 20 pills, three times daily, orally for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this group will receive Naoxuekang Dropping Pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care. Receives: Drug: Naoxuekang Dropping Pills |
| Control Group | Placebo comparator | Participants in this group will receive matched placebo pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care. Receives: Drug: Naoxuekang Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Composite Vascular Events
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).
Measured: Within 1 year after the onset of intracerebral hemorrhage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start10 Oct 2025 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: the Naoxuekang group or the placebo control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Beijing Kangerfu Pharmaceutical Company Limited
- Responsible party
- Sponsor
- Investigators
- Qian Zhang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200921
- Sponsor's protocol ID
- 2024ZD0522203
- Acronym
- TCM-ICH
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills
- ClinicalTrials.gov ID
- NCT07200921
- Acronym / sponsor ID
- TCM-ICH / 2024ZD0522203
- Keywords
- Hypertensive intracerebral hemorrhage, Cerebral small vessel disease, Naoxuekang Dropping Pills, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Beijing Kangerfu Pharmaceutical Company Limited
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: the Naoxuekang group or the placebo control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Naoxuekang Dropping PillsParticipants in this group will receive Naoxuekang Dropping Pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care. |
| Control Group | Placebo comparator | Drug: Naoxuekang Matching PlaceboParticipants in this group will receive matched placebo pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naoxuekang Dropping PillsA traditional Chinese medicine. Each pill weighs 35mg. Dosage: 20 pills, three times daily, orally for 90 days. | Drug | Experimental Group |
| Naoxuekang Matching PlaceboA placebo pill matched to Naoxuekang Dropping Pills in appearance, taste , size, and packaging. Dosage: 20 pills, three times daily, orally for 90 days. | Drug | Control Group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qian Zhang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naoxuekang Dropping Pills in people with Hypertensive Intracerebral Hemorrhage and Cerebral Small Vessel Diseases, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xintong Song, MD (010-17519241291, Songxt1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Composite Vascular Events (time frame: Within 1 year after the onset of intracerebral hemorrhage.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.