NCT03546283

Neuroprotectant for Hypertensive Intracerebral Hemorrhage

Efficacy and Safety of Neuroprotectant Cattle Encephalon Glycoside and Ignotin Injection for Intracerebral Hemorrhage: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (estimated)
• Sponsor: Rong Hu, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a compound preparation of muscle extract from healthy rabbits and cattle brain gangliosides, which was approved by the Chinese Food and Drug Administration in 2011 and was commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China. To evaluate the safety and efficacy of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study.

Detailed description

Hypertensive intracerebral hemorrhage (HICH) is a type of stroke that is caused by hypertension-induced intracranial arterial, venous, and capillary ruptures. In recent years, the incidence of HICH has become higher, which has exposed society greatly to heavy social and economic burdens. Therefore it is necessary to find therapeutic strategies. ICH causes primary white matter injury by direct mechanical compression and hematoma expansion, and then it induces secondary injury through toxic product from the blood out of the vessel. The inflammatory response that follows ICH also contributes to the white matter injury. Additionally, post-ICH complications that include cortical thinning, cerebral edema, and hydrocephalus further aggravate the subcortical white matter damage. The complex injury mechanisms that follow ICH implies that a multi-target neuroprotective agent might be able to achieve better neuroprotective effects than current single-agent neuroprotective therapies. Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a multi-target neuroprotective agent that includes polypeptides, various gangliosides, free amino acids and nucleic acids, which were extracted from muscle tissue of healthy rabbits and cattle brain gangliosides, and was approved by the Chinese Food and Drug Administration in 2011, commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China. It has been proven by basic research that CEGI treatment significantly alleviated the neurobehavioral dysfunction, promoted hematoma absorption, effectively up-regulated MBP/MAP-2 expression, and ameliorated white matter fiber damage \[1\]. CEGI was frequently used in the treatment of intracerebral hemorrhage, yet there is still a lack of high quality study to demonstrate its clinical efficacy. To achieve more clinical evidence of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study to further evaluate the efficacy and safety of CEGI in the treatment of Hypertensive intracerebral hemorrhage.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Placebos	The patients with hypertensive intracerebral hemorrhage will be randomized into giving placebos, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
DRUG	Cattle Encephalon Glycoside and Ignotin	The patients with hypertensive intracerebral hemorrhage will be randomized into giving CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-07-31
• Completion: 2020-12-31
• First posted: 2018-06-06
• Last updated: 2018-06-06

Locations

1 site across 1 country: China