Chronic Subdural HematomaCHARMNCT06427980
Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma
A study testing Chinese Herbal formula HuoXue LiShui in people with Chronic Subdural Hematoma, run by Beijing Tiantan Hospital at 3 sites in China.
Trial summary
A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Chinese Herbal formula HuoXue LiShui
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2025to 28 Mar 2026
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years and either gender will be included.
- Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).
- Primary hematoma or residual hematoma after burr-hole drainage.
- Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤ 2.
- No risk of brain herniation or recent immediate need for surgery will be evaluated by 2 attending neurosurgeons.
- Written informed consent will be obtained from patients or their next of kins according to their cognitive status.
Who cannot join
- Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.
- Progressive or apparent neurological deficit with a GCS score < 14 or mRS score > 2.
- Midline shift > 10 mm on the radiological image.
- Previous medication treatment for CSDH.
- Previous intracranial surgery for any other neurological disorder.
- Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.
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- Known hypersensitivity or allergy to HXLS or to any of the ingredients.
- Malignant tumors.
- Life expectancy of < 1 year.
- Abnormal liver function or liver diseases, including uncontrolled hepatitis (alanine transaminase > 120 U/L).
- Severe renal impairment (estimated glomerular filtration rate < 30 ml/min or serum creatinine > 150 μmol/L).
- Moderate or severe anemia (hemoglobin ≤ 90 g/L).
- Severe coagulopathy or a high risk of life-threatening bleeding.
- Poor medication conditions or the presence of severe comorbidities such that treatment cannot be tolerated or follow-up cannot be completed.
- Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, angiotensin-converting enzyme inhibitors, or other traditional Chinese medicines before randomization or are expected to take such medications in the next 24 weeks.
- Difficulty swallowing oral medication.
- Pregnancy or lactation.
- Participating in another study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
First People's Hospital of Lianyungang
Lianyungang, Jiangsu
About this study
Official title: Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail
A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.
Read the detailed description
The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of the Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH in an effort to prevent surgery. The investigators hypothesize that, compared with placebo, the Chinese herbal formula HXLS reduce incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and the placebo group at a 1:1 ratio.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Chinese Herbal formula HuoXue LiShui, Chinese Herbal formula Placebo
- Keywords
- Chronic Subdural Hematoma, Chinese herbal formula, HuoXue LiShui, Pharmacotherapy, Randomized controlled trial
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal formula HuoXue LiShuiDrug
Also called HuoXue LiShui
The intervention consists of the oral administration of granule with either HXLS or a placebo substance, one bag (28.5 g) twice daily after meals for a period of 8 weeks. The granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonuri Herbal, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthami Flos, 6.0g).
Chinese Herbal formula PlaceboDrug
Also called Placebo
The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. In terms of outer packing, the HXLS and placebo granules will be exactly the same. It included Hu Jing (28.5g)
| Study group | Role | What they receive |
|---|---|---|
| HXLS group | Experimental | The HXLS granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthamus tinctorius L, 6.0g). Receives: Drug: Chinese Herbal formula HuoXue LiShui |
| placebo group | Placebo comparator | The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. It included Hu Jing (28.0g) Receives: Drug: Chinese Herbal formula Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of operation
Surgical rate of hematoma recurrence due to progression of primary hematoma or after burr hole drainage
Measured: From baseline up to 24 weeks after the start of treatment with the study medication
Secondary outcomes (9)
Chronic subdural hematoma volume
CSDH volume measured on head CT
Measured: At baseline, and at 4, 8 and 24 weeks
Change of Modified Rankin Scale (MRS) between group
Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.
Measured: At baseline, and at 4, 8, and 24 weeks
Change of Markwalder Grading Scale (MGS) between groups
Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.
Measured: At baseline, and at 4, 8, and 24 weeks
Change of Quality of life
A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'.
Measured: At baseline, and at 4, 8, and 24 weeks
Change of performance in activities of daily living
The Barthel Index is scored from 0 to 100. >60 is good, with mild dysfunction, able to perform some activities of daily living independently, and needing some help; 60-41 is moderate. 60-41 is classified as moderate, with moderate dysfunction, requiring a great deal of help to complete activities of daily living; ≤40 is classified as poor, with severe dysfunction, unable to complete most of the activities of daily living or needing help from others.
Measured: At baseline, and at 4, 8, and 24 weeks
Change of cognitive functioning
The Montreal Cognitive Assessment (MOCA) score is an assessment tool designed to facilitate rapid screening for abnormalities in cognitive functioning. It encompasses 11 screening items across eight cognitive domains, including attention and concentration, executive function, memory, language, visual structural skills, abstract thinking, calculation, and orientation. A total score of 30 or above 26 is indicative of normal cognitive function.
Measured: At baseline, and at 4, 8, and 24 weeks
Number of falling incidents
Number of falling incidents
Measured: At 24 weeks
Mortality
Mortality
Measured: At 24 weeks
Rate of complications and adverse events between groups
Rate of complications and adverse events between groups
Measured: Within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Liu, Beijing Tiantan Hospital
- Investigators
- Weiming Liu, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427980
- Sponsor's protocol ID
- KY2023-265
- Acronym
- CHARM
- Status last verified
- Dec 2024
- First submitted
- 20 May 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail
- ClinicalTrials.gov ID
- NCT06427980
- Acronym / sponsor ID
- CHARM / KY2023-265
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic Subdural Hematoma, Chinese herbal formula, HuoXue LiShui, Pharmacotherapy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 24 May 2024 (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.
A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.
Detailed description
The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of the Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH in an effort to prevent surgery. The investigators hypothesize that, compared with placebo, the Chinese herbal formula HXLS reduce incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and the placebo group at a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HXLS group | Experimental | Drug: Chinese Herbal formula HuoXue LiShuiThe HXLS granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthamus tinctorius L, 6.0g). |
| placebo group | Placebo comparator | Drug: Chinese Herbal formula PlaceboThe placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. It included Hu Jing (28.0g) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 90 years and either gender will be included.
- Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).
- Primary hematoma or residual hematoma after burr-hole drainage.
- Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤ 2.
- No risk of brain herniation or recent immediate need for surgery will be evaluated by 2 attending neurosurgeons.
Key exclusion criteria (18 listed)
- Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.
- Progressive or apparent neurological deficit with a GCS score < 14 or mRS score > 2.
- Midline shift > 10 mm on the radiological image.
- Previous medication treatment for CSDH.
- Previous intracranial surgery for any other neurological disorder.
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 |
|---|---|---|
| Chinese Herbal formula HuoXue LiShuiAlso: HuoXue LiShuiThe intervention consists of the oral administration of granule with either HXLS or a placebo substance, one bag (28.5 g) twice daily after meals for a period of 8 weeks. The granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonuri Herbal, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthami Flos, 6.0g). | Drug | HXLS group |
| Chinese Herbal formula PlaceboAlso: PlaceboThe placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. In terms of outer packing, the HXLS and placebo granules will be exactly the same. It included Hu Jing (28.5g) | Drug | placebo group |
Primary outcome
Rate of operation
Time frame: From baseline up to 24 weeks after the start of treatment with the study medication
Surgical rate of hematoma recurrence due to progression of primary hematoma or after burr hole drainage
9 secondary outcomes
Chronic subdural hematoma volume
Time frame: At baseline, and at 4, 8 and 24 weeks
Change of Modified Rankin Scale (MRS) between group
Time frame: At baseline, and at 4, 8, and 24 weeks
Change of Markwalder Grading Scale (MGS) between groups
Time frame: At baseline, and at 4, 8, and 24 weeks
Change of Quality of life
Time frame: At baseline, and at 4, 8, and 24 weeks
Change of performance in activities of daily living
Time frame: At baseline, and at 4, 8, and 24 weeks
Change of cognitive functioning
Time frame: At baseline, and at 4, 8, and 24 weeks
Number of falling incidents
Time frame: At 24 weeks
Mortality
Time frame: At 24 weeks
Rate of complications and adverse events between groups
Time frame: Within 24 weeks
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 30 Dec 2024.
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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.
Weiming Liu, M.D. principal investigator
Beijing Tiantan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Herbal formula HuoXue LiShui in people with Chronic Subdural Hematoma, run by Beijing Tiantan Hospital at 3 sites 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 6 inclusion and 18 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 Liang Wu, M.D. (15001333582, wuliang@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of operation (time frame: From baseline up to 24 weeks after the start of treatment with the study medication). 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 30 Dec 2024.