A Phase 4 interventional study of Huperzine A for Injection in Neurosensory Disorder, sponsored by Jiangsu Famous Medical Technology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Jiangsu Famous Medical Technology Co., Ltd. · Phase 4, Interventional, and Treatment
A randomized, controlled, single-center, exploratory clinical research method was used. In the treatment plan, the experimental group used basic treatment + Huperzine A, and the control group only used basic treatment, with a total of 20 cases. To evaluate the effectiveness and safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Jiangsu Famous Medical Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Huperzine A for Injection: Dissolve each bottle with 2ml sterile water for injection and inject into muscle, the course of treatment is 14 days； Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training.
Drug: Huperzine A for Injection
Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training.
Give the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
At the 90-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Time frame: At the 90-day
Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment
At the 30-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Time frame: At the 30-day
Scores of Modified Rankin Scale(mRS) at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Time frame: At the 14-day
Scores of Modified Rankin Scale(mRS) at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Time frame: At the 30-day
Scores of Modified Rankin Scale(mRS) at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Time frame: At the 90-day
Scores of National Institute of Health stroke scale(NIHSS) at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Time frame: At the 14-day
Scores of National Institute of Health stroke scale(NIHSS) at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Time frame: At the 30-day
Scores of National Institute of Health stroke scale(NIHSS) at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Time frame: At the 90-day
Scores of the Barthelindex of ADL at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Time frame: At the 14-day
Scores of the Barthelindex of ADL at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Time frame: At the 30-day
Scores of the Barthelindex of ADL at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Time frame: At the 90-day
Complication rate
After 90 days of treatment, compare whether the incidence of complications (including epilepsy, hydrocephalus, infarction, rebleeding, pneumonia, gastrointestinal hemorrhage) between the two groups is statistically different
Time frame: At the 90-day
Plan to share: Undecided
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Jiangsu Famous Medical Technology Co., Ltd.