Chinese Herbal Medicine in Acute INtracerebral Haemorrhage (CHAIN) 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.

Timeline

Start

2021-10

Primary completion

2024-12

Completion

2025-01

Outcome

Missed primary endpoint

paper Mean utility weighted modified Rankin Scale scores at 90 days were 0·44 in the FYTF-919 group and 0·44 in the placebo group (difference 0·01, 95% CI -0·02 to 0·04; p=0·63). PMID 39547249 ↗

Publications

• 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.

Drugs

Indications