The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWanbangde Pharmaceutical Group Co., LTD

About this trial

Under the premise of basic treatment, to explore the improvement effect of huperzine A injection on short-term and long-term neurocognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage after interventional/surgical treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70;

The patients were proved to be aneurysmal subarachnoid hemorrhage by imaging examination (head CT, CT angiography (CTA), whole brain angiography (DSA));

Hunt Hess was graded I-III at admission;

The patients were treated with endovascular therapy or craniotomy and clipping surgery;

Disqualifiers

Non aneurysmal subarachnoid hemorrhage;

Cognitive dysfunction existed before onset;

Patients with angina pectoris, bronchial asthma, mechanical intestinal obstruction, liver and kidney insufficiency, and urinary tract obstruction;

Complicated with other nervous system diseases, including nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, Lewy body dementia, frontotemporal dementia, etc.), neuromyelitis optica, epilepsy, central nervous system infection (such as AIDS, syphilis, etc.), brain traumatic dementia, etc;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Huperzine A injection, operational treatment, the best basic treatment

    Drug

    intramuscular

  • operational treatment, the best basic treatment

    Other intervention

    other

  • Huperzine A injection, interventional treatment, the best basic treatment

    Drug

    intramuscular

  • Interventional treatment, the best basic treatment

    Other intervention

    other

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: The operation group-The treatment groupExperimental treatment 1 intervention
Group B: The operation group-The control groupOther 1 intervention
Group C: The intervention group-The treatment groupExperimental treatment 1 intervention
Group D: The intervention group-The control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Mini Mental Status Examination(MMSE )

The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.

Time frame
90 days after discharge

Secondary outcomes

1

Hospital anxiety and depression Scale(HADS)

The anxiety and depression subscales of the Hospital Anxiety and Depression Scale were used to screen the anxiety and depression of the subjects before treatment, at the end of medication and at the visit period after discharge, and the intra group and inter group comparisons were made. The higher the score, the more serious the anxiety or depression.

Time frame
Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
2

The Short Form-36 Health Survey

Calculate the eight items in the scale. Before and after treatment, the scores of each items and the total score of body and psychology were compared within and between groups.

Time frame
Screening period (day -4 to day 0), 30 days after discharge, 90 days after discharge and 180 days after discharge
3

Modified Rankin Score

The functional recovery outcomes before treatment, at the end of medication and at the visit period after discharge were evaluated by using the modified Rankin scale, and compared within and between groups. The higher the score, the worse the functional recovery.

Time frame
Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
4

Biological sample detection

Biological samples were tested during the screening period, during the medication period, and after the medication period to obtain drug metabolomics analysis data and disease biomarker data, and intra-group and inter-group comparisons were performed.

Time frame
Screening period (day -4 to day 0), day 2, day 3, day 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wanbangde Pharmaceutical Group Co., LTD

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Collaborator

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