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Chinese Herbal Medicine in Acute INtracerebral Haemorrhage (CHAIN) Trial

NCT05066620 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2021-10-04

No results posted yet for this study

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.

Conditions

  • Intracerebral Hemorrhage

Interventions

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)

Sponsors & Collaborators

  • The George Institute

    collaborator OTHER

  • Guangzhou University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Craig Anderson, MD · The George Institute for Global Health, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066620 on ClinicalTrials.gov