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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05066620
Other study ID # 2020B1111100009
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date October 2021
Est. completion date January 2025

Study information

Verified date September 2021
Source Guangzhou University of Traditional Chinese Medicine
Contact Jianwen Guo, MD
Phone +86-13724899379
Email jianwen_guo@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.


Description:

A multicentre, prospective, randomised, double-blind, placebo-controlled trial to be conducted through hospital network of investigators in China. A total of 1504 patients with ICH will be recruited from approximately 20-30 hospitals. Randomised is via a central internet-based system according to block random grouping method stratified by site, neurological severity NIHSS <15 vs ≥15), and haematoma location (basal ganglia + lobe vs thalamus + cerebellum + brain stem + ventricle) to ensure balance in key prognostic factors. Endpoint assessment will be blinded to treatment allocation. The primary aim of this study is to determine the effectiveness and safety of a Chinese herbal medicine FYTF-919 as compared to placebo on functional recovery according to Utility-weighted modified Rankin scale (UW-mRS) at 90 days after acute ICH. Secondary aims include examining whether the Chinese herbal medicine FYTF-919 leads to positive treatment effect on: 1) Utility-weighted mRS scores at 180 days; 2)Ordinal analysis of 7 levels of mRS at 28 days, 90 days and 180 days; 3) Poor prognosis, defined as mRS 4-6 points at 28 days, 90 days and 180 days; 4) NIHSS score at 7 days and 28 days; 5) Mortality rate at 28 days, 90 days and 180 days; 6) Discharge rate at 28 days; 7) EQ-5D-5L at 28days, 90 days and 180 days; 8) BI at 28 days, 90 days and 180 days; 9) The cerebral edema volume at baseline, 24 hours, 7 days, 14 days or at discharge; 10) The hematoma volume at baseline, 24 hours, 7 days, 14 days or discharge; 11) The incidence of stroke-associated pneumonia (SAP) patients; 12) Clinical pulmonary infection score (CIPS) at the onset of SAP, 3 days, and 7 days, after the occurrence of SAP; 13) Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture at the onset of SAP, 3 days, and 7 days after the occurrence of SAP; 14) Antibiotic usage among patients with SAP.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1504
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 years; 2. Diagnosis of spontaneous ICH, confirmed by brain imaging; 3. Presentation within 48 hours of symptom onset (or last seen well); 4. Meet any of the following criteria: a) NIHSS =8, or b) GCS 7-14; 5. Provide written informed consent by patient (or approved surrogate); Exclusion Criteria: 1. ICH secondary to a structural abnormality in the brain (e.g. cerebrovascular malformation, arterial aneurysm, tumour, Moyamoya disease, trauma, or previous ischaemic stroke), or secondary to presumed cerebrovascular amyloidosis, or secondary to reperfusion treatment for ischaemic stroke, or secondary to anticoagulant treatment, or secondary to antiplatelet treatment. 2. Unlikely to potentially benefit from therapy (e.g. advanced dementia) or judged by responsible treating clinician to have a high likelihood of early death irrespective of treatment; 3. Other medical illness that will interfere with outcome assessments and follow-up (e.g. known significant pre-stroke disability [modified Rankin scale {mRS} scores 4-5], advanced cancer and renal failure); 4. Known definite contraindication to the Chinese herbal medicine; 5. Women who are known to be pregnant or lactating; 6. Currently participating in another trial which would interfere with outcome assessments.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chinese herbal medicine FYTF-919
Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding)

Locations

Country Name City State
China Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangzhou University of Traditional Chinese Medicine The George Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Utility-weighted modified Rankin scale scores Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome. 90 days after the treatment started
Secondary Utility-weighted mRS scores Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome. 180 days after the treatment started
Secondary 7 levels of mRS Ordinal analysis of 7 levels of mRS. The value range 0-6: higher scores mean a worse outcome. 28 days, 90 days and 180 days after the treatment started
Secondary Poor prognosis rate Binary variable: 1 means mRS 4-6 points; 0 means mRS is 0-3 points. 28 days, 90 days and 180 days after the treatment started
Secondary NIHSS score National Institute of Health Stroke Scale Score. The value range 0-42: higher scores mean a worse outcome. 7 days and 28 days after the treatment started
Secondary Mortality rate Mortality rate 28 days, 90 days and 180 days
Secondary Discharge rate Discharge rate 28 days after the treatment started
Secondary European Quality of Life 5-dimensional questionnaire (EQ-5D-5L) The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: higher scores mean a worse outcome. 28 days, 90 days and 180 days after the treatment started
Secondary BI Barthel index. The value range 0-100: higher scores mean a better outcome. 28 days, 90 days and 180 days after the treatment started
Secondary The cerebral edema volume The cerebral edema volume Baseline, 24 hours, 7 days, 14 days or at discharge
Secondary The hematoma volume The hematoma volume Baseline, 24 hours, 7 days, 14 days or discharge
Secondary SAP The incidence of stroke-associated pneumonia patients Baseline, 24 hours, 7 days, 14 days or discharge
Secondary CPIS Clinical pulmonary infection score. The value range 0-12: higher scores mean a worse outcome. The onset of SAP, 3 days and 7 days after the occurrence of SAP
Secondary Pulmonary infection Diagnosed by using the Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture The onset of SAP, 3 days and 7 days after the occurrence of SAP
Secondary Antibiotic usage Antibiotic usage among patients with SAP The onset of SAP, 3 days and 7 days after the occurrence of SAP
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