Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

— CHARM  

Official title:

Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma: a A Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427980
• Other study ID #: KY2023-265
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Liang Wu, M.D.
• Phone: 15001333582
• Email: wuliang[@]bjtth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, randomized, double-blinded, placebo-controlled, multicenter trail is designed to compare differences of operation rate and clinical outcome from treatment up to 24 weeks between HXLS group and placebo group.

Description:

The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH, in an effort to prevent surgery. We hypothesize that compared with placebo, Chinese herbal formula HXLS reduces operation rates 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 placebo group at 1:1 ratio.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age between 18 years and 90 years and either gender.

2. Supratentorial, unilateral or bilateral CSDH verified on cranial CT or magnetic resonance imaging.

3. Stable vital signs and neurological deficit with GCS score = 14 and modified Rankin Scale (mRS) score = 2.

4. No risk of brain herniation and recent immediate needs for surgery evaluated by 2 attending neurosurgeons.

5. Written informed consent from patients or their next of kin according to the patient's cognitive status.

Exclusion Criteria:

1. Unstable vital signs or symptoms of brain herniation including severe headache, nausea and vomiting, or disturbed consciousness.

2. Progressive or apparent neurological deficit with GCS score < 14 or mRS score > 2.

3. Midline shift > 10 mm on radiological image.

4. Previous treatment (surgery or medication) for CSDH.

5. Previous intracranial surgery for any other neurological disorders.

6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.

7. Known hypersensitivity or allergy to HXLS or to any of the ingredients.

8. Malignant tumor.

9. Abnormal liver function or liver diseases including uncontrolled hepatitis (alanine transaminase > 120U/L).

10. Severe renal impairment (estimated glomerular filtration rate < 30ml/min or serum creatinine > 150µmol/L).

11. Moderate or severe anemia (hemoglobin = 90g/L).

12. Severe coagulopathy or high risk of life-threatening bleeding.

13. Existing poor medication condition or severe comorbidity so that treatment cannot be tolerated, or follow-up cannot be completed.

14. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, or other traditional Chinese medicine before randomization or who are expected to take such medications in the next 24 weeks.

15. Difficulty in swallowing oral medication.

16. Pregnancy or lactation.

17. Participating in another research.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Chinese Herbal formula 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 (???, Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (???, Hirudo, 1.5g), Tao Ren (??, Semen persicae, 6.0g), and Hong Hua (??, Carthamus tinctorius L, 6.0g).
• Chinese Herbal formula 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)

Locations

Country	Name	City	State
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	Beijing
China	First People's Hospital of Lianyungang	Lianyungang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of operation	Rate of operation	From baseline up to 24 weeks after the start of treatment with the study medication
Secondary	Chronic subdural hematoma volume	CSDH volume measured on head CT	At baseline, and at 4, 12, and 24 weeks
Secondary	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.	At baseline, and at 1, 4, 8, 12, and 24 weeks
Secondary	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.	At baseline, and at 1, 4, 8, 12, and 24 weeks
Secondary	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'.	At baseline, and at 4, 8, 12, and 24 weeks
Secondary	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.	At baseline, and at 4, 8, 12, and 24 weeks
Secondary	Change of cognitive functioning	Montreal Cognitive Assessment, MOCA score	At baseline, and at 4, 8, 12, and 24 weeks
Secondary	Number of falling incidents	Number of falling incidents	At 24 weeks
Secondary	Mortality	Mortality	At 24 weeks
Secondary	Rate of complications and adverse events between groups	Rate of complications and adverse events between groups	Within 24 weeks