An interventional study of Chinese Herbal formula HuoXue LiShui and Chinese Herbal formula Placebo in Chronic Subdural Hematoma, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
Among 17 studies in Hematoma, Subdural, Chronic with a site in China — 9 open to participants now, 9 under way, none of them phase 3. Hematoma, Subdural, Chronic · China.
Among the 17 studies in Hematoma, Subdural, Chronic with a site in China, this one is the 10th largest by planned enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2025, is one of 12 with no phase, and was the 13th registered.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 160 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →9 of the 17 studies in Hematoma, Subdural, Chronic with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 35 Hematoma, Subdural, Chronic studies recruiting now, 26 (74%) set no upper age limit and 1 (3%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2025.
Median enrollment 200 across the 15 interventional studies, 440 across the 2 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
1 of 17 have an industry lead sponsor. The 9 most frequent:
Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Beijing Tiantan Hospital has 6 studies filed under Hematoma, Subdural, Chronic — fewer than ten, so there is no comparison to draw.
2 of the studies in Hematoma, Subdural, Chronic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401772Huashan HospitalThe Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma | 2026-12 |
| NCT07144423Beijing Tiantan HospitalNeuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma | 2027-07-31 |
Among the 17 studies in Hematoma, Subdural, Chronic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Chinese Herbal formula HuoXue LiShui
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)
Drug: Chinese Herbal formula Placebo
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).
Also known as: HuoXue LiShui
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)
Also known as: Placebo
Rate of operation
Surgical rate of hematoma recurrence due to progression of primary hematoma or after burr hole drainage
Time frame: From baseline up to 24 weeks after the start of treatment with the study medication
Chronic subdural hematoma volume
CSDH volume measured on head CT
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, and at 4, 8, and 24 weeks
Number of falling incidents
Number of falling incidents
Time frame: At 24 weeks
Mortality
Mortality
Time frame: At 24 weeks
Rate of complications and adverse events between groups
Rate of complications and adverse events between groups
Time frame: Within 24 weeks
Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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