Chinese Herbal Medicine in Acute INtracerebral Haemorrhage (CHAIN) Trial

NCT05066620 | Unknown Phase 3 DMC

• 1 other identifier: 2020B1111100009
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intracerebral haemorrhage; Functional recovery; Chinese herbal medicine; Stroke; Clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Utility-weighted mRS scores

  180 days after the treatment started

• 7 levels of mRS

  28 days, 90 days and 180 days after the treatment started

• Poor prognosis rate

  28 days, 90 days and 180 days after the treatment started

• NIHSS score

  7 days and 28 days after the treatment started

• Mortality rate

  28 days, 90 days and 180 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Drug: Chinese herbal medicine FYTF-919

Control group

PLACEBO COMPARATOR

Placebo treatment: Oral liquid 33ml TID (or patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Drug: Chinese herbal medicine FYTF-919

Interventions

Chinese herbal medicine FYTF-919 DRUG

Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Also known as: Chinese herbal medicine

Control group; Intervention group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Diagnosis of spontaneous ICH, confirmed by brain imaging;
• Presentation within 48 hours of symptom onset (or last seen well);
• Meet any of the following criteria: a) NIHSS ≥8, or b) GCS 7-14;
• Provide written informed consent by patient (or approved surrogate);

You may not qualify if:

• 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.
• 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;
• 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);
• Known definite contraindication to the Chinese herbal medicine;
• Women who are known to be pregnant or lactating;
• Currently participating in another trial which would interfere with outcome assessments.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• The George Institute: collaborator

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Guo J, Chen X, Wu M, Wang D, Zhao Y, Li Q, Tang G, Che F, Xia Z, Liang Z, Shi L, Jiang Q, Chen Y, Liu X, Ren X, Ouyang M, Wang B, You S, Billot L, Wang X, Liu Z, Jing H, Meng W, Tian S, Liu E, Xiang Y, Tang X, Xie T, Cui W, Zheng Y, Cao J, Zhang J, Wen Z, Huang T, Wang L, You C, Pan S, Cai Y, Lu Y, Hankey GJ, Al-Shahi Salman R, Anderson CS, Song L; CHAIN investigators. Traditional Chinese medicine FYTF-919 (Zhongfeng Xingnao oral prescription) for the treatment of acute intracerebral haemorrhage: a multicentre, randomised, placebo-controlled, double-blind, clinical trial. Lancet. 2024 Nov 30;404(10468):2187-2196. doi: 10.1016/S0140-6736(24)02261-X. Epub 2024 Nov 12.

  PMID: 39547249 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig Anderson, MD

  The George Institute for Global Health, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwen Guo, MD

CONTACT

+86-13724899379; jianwen_guo@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 4, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

Locations

CN (1)