Cognitive DeclinePhase 4NCT00297245
Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass
A Phase 4 study testing cognitive function in people with Cognitive Decline, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- cognitive function
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2006to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergo mitral valve replacement surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Union Hospital
Wuhan, Hubei, 430022
Shihai Zhang, M.D., Ph.D., 862-785-726-834, zhangshh@public.wh.hb.cn
Shihai Zhang, M.D., Ph.D.
About this study
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.
- Conditions
- Cognitive Decline
- Being tested
- cognitive function
- Keywords
- gastrodin
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive functionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass
Secondary outcomes (1)
neuropsychological tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Investigators
- Shihai Zhang, Principal investigator, Department of Anesthesiology, Union Hosiptal, Tongji Medical College, Huazhong University of Science and TechnologyShihai Zhang, M.D., Ph.D., Principal investigator, Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297245
- Sponsor's protocol ID
- 21124941
- Status last verified
- Jan 2006
- First submitted
- 27 Feb 2006
- Last updated
- 28 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00297245
- Acronym / sponsor ID
- 21124941
- Conditions
- Cognitive Decline
- Keywords
- gastrodin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- May 2006
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergo mitral valve replacement surgery.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive function | Drug | – |
Primary outcome
Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass
1 secondary outcome
neuropsychological tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cognitive function in people with Cognitive Decline, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shihai Zhang, M.D.,Ph.D. (862-785-726-834, zhangshh@public.wh.hb.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2006; AzTrials last refreshed its copy on 8 Nov 2026.