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Status unknownNCT00297245Updated Feb 28, 2006

Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

A Phase 4 interventional study of cognitive function in Cognitive Decline, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-02-28.

Sponsored by Huazhong University of Science and Technology · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance.However, there is no method to prevent the decline.Gastrodin,the active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Gastrodin is safe. No severe side-effect has been observed in the treatment. We postulate that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

Read the detailed description

Cardiac surgery with cardiopulmonary bypass (CPB) is one of the most frequently performed operations. Neurobehavioral disorders, including neuropsychiatric and neuropsychological deficits, are a very frequently reported sequela of valve replacement or coronary artery bypass grafting (CABG) surgery. CPB is associated with significant cerebral morbidity. The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance. Neurocognitive decline can present days to weeks after surgery and may remain a permanent disorder. Many pharmacologic strategies have been proposed or investigated for preventing post-CPB cognitive decline, but to our knowledge, none of these drugs has been systematically evaluated for efficacy in preventing post-CPB cognitive decline.

The causative parameters of cognitive dysfunction associated with CPB include cerebral ischemia secondary to either microemboli or hypoperfusion, intraoperative cerebrovascular risk factors such as the duration of CPB, inflammatory response, cerebral glutamine release, free radicals, and NO release.

Gastrodia elata, a famous Chinese medical herb, has effects on preventing ischemic brain injury, neuronal cell damage or apoptosis, suppressing inflammatory response, inhibiting glutamine receptors and nNOS, and scavenging free radicals. Gastrodin (4-[hydroxymethyl]phenyl-β-D-glucopyranoside), the primary active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Based on its pharmacological effects, we postulated that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

02

Conditions studied

  • Cognitive Decline

Keywords

  • gastrodin
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 200 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients undergo mitral valve replacement surgery.

Exclusion criteria

Exclusion Criteria:

  • Thrombi in left atrium, a history of symptomatic cerebrovascular disease, diabetes, psychiatric illness, renal disease, or active liver disease, less than a seven-grade education, or who cannot read.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
200 participants

Interventions

  • Drugcognitive function
06

What researchers measure

Primary outcomes

  1. Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass

Secondary outcomes

  1. neuropsychological tests

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology, Union Hospital
    Wuhan, Hubei 430022, China
    • Shihai Zhang, M.D., Ph.D. · Contact · zhangshh@public.wh.hb.cn · 862-785-726-834
    • Shihai Zhang, M.D., Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00297245
Lead sponsor
Huazhong University of Science and Technology
First posted
Feb 28, 2006
Start date
Feb 2006
Completion
May 2006
Last update
Feb 28, 2006

Study contacts

Shihai Zhang, M.D.,Ph.D.
Contact
zhangshh@public.wh.hb.cn
862-785-726-834
Shihai Zhang, M.D., Ph.D.
Contact
zhangshh@public.wh.hb.cn
862-785-726-834
Shihai Zhang
principal investigator · Department of Anesthesiology, Union Hosiptal, Tongji Medical College, Huazhong University of Science and Technology
Shihai Zhang, M.D., Ph.D.
principal investigator · Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

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