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

NCT06427980 | Not Yet Recruiting DMC

• 1 other identifier: KY2023-265
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic Subdural Hematoma; Chinese herbal formula; HuoXue LiShui; Pharmacotherapy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Rate of operation

  Surgical rate of hematoma recurrence due to progression of primary hematoma or after burr hole drainage

  From baseline up to 24 weeks after the start of treatment with the study medication

Secondary Outcomes (9)

• Chronic subdural hematoma volume

  At baseline, and at 4, 8 and 24 weeks

• Change of Modified Rankin Scale (MRS) between group

  At baseline, and at 4, 8, and 24 weeks

• Change of Markwalder Grading Scale (MGS) between groups

  At baseline, and at 4, 8, and 24 weeks

• Change of Quality of life

  At baseline, and at 4, 8, and 24 weeks

• Change of performance in activities of daily living

  At baseline, and at 4, 8, and 24 weeks

Study Arms (2)

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).

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)

Drug: Chinese Herbal formula Placebo

Interventions

Chinese Herbal formula HuoXue LiShui DRUG

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

HXLS group

Chinese Herbal formula Placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (3)

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 101100, China

Location

First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Weiming Liu, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wu, M.D.

CONTACT

15001333582; wuliang@bjtth.org

Weiming Liu, M.D.

CONTACT

13701182770; liuweimingnsok@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators in charge of the recruitment and follow-up evaluation and participants will be blinded, along with the outcome assessors and data analysts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 28, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

CN (3)