Post-stroke Cognitive ImpairmentEarly Phase 1NCT05731310
Clinical Study of Angong Niuhuang Pill and Acupuncture on PSCI Angong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
A Early Phase 1 study testing Angong Niuhuang Pill in people with Post-stroke Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Post stroke cognitive impairment (PSCI) refers to the attainment of cognitive impairment after the clinical event of stroke A range of syndromes that impede diagnostic criteria. Epidemiologically, PSCI is one of the common complications in stroke patients Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Post-stroke Cognitive Impairment
- What is being tested?
- Angong Niuhuang Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2024
- Phase
- Early Phase 1
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All were the first stroke, confirmed by head computed tomography (CT) or magnetic resonance imaging (MRI), with vital signs
- stable; (2) Those who are conscious and can cooperate with relevant treatment; (3) Montreal Cognitive Assessment Scale (MoCA) score ≤ 24 points; （4）
- The course of disease is more than 1 month, and the patient is 40-70 years old.
Who cannot join
- People with cognitive impairment before onset; (2) There are contraindications of Angong Niuhuang Pill or electroacupuncture treatment;
- Complicated with dysfunction of heart, liver, kidney and other important organs; (4) Previous history of cerebral hemorrhage, epilepsy, brain injury, etc; (5) Before onset
- Have a history of alcohol and drug dependence; (6) The condition worsens, and new hemorrhagic or infarcted foci appear.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
le zhang, 86-13616511229, 2319053@zju.edu.cn
About this study
Official title: Efficacy Evaluation and Evaluation of Peripheral Neuroprotective Mechanism of Amgong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
Post stroke cognitive impairment (PSCI) refers to the attainment of cognitive impairment after the clinical event of stroke A range of syndromes that impede diagnostic criteria. Epidemiologically, PSCI is one of the common complications in stroke patients
Read the detailed description
(1) Clinical scale data of cognitive function, daily living ability of PSCI patients integrated with the research of this project using uterine Niu Huang pill combined with examined pulse music electroacupuncture
For analysis, the efficacy of PSCI patients was observed; (2) In depth studies on auditory event-related potentials of PSCI treated by uterine Niu Huang pill combined with examined pulse music electroacupuncture
The changes of serum related nerve growth factor and the relationship between each other in order to enrich / fill our province's research results in this field; (3) In key academic journals
1 high level scientific research paper published.
- Conditions
- Post-stroke Cognitive Impairment
- Being tested
- Angong Niuhuang Pill
- Keywords
- Post-stroke cognitive impairment;acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angong Niuhuang PillDrug
Also called Angong Niuhuang pill combined with music scalp acupuncture group
Take Angong Niuhuang pill half a pill/day； Angong Niuhuang pill combined with music scalp acupuncture group These operations last for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Angong Niuhuang Pill Group | Experimental | Take half an Angong Niuhuang pill every day for 4 weeks Receives: Drug: Angong Niuhuang Pill |
| Angong Niuhuang pill combined with music electroacupuncture group | Experimental | Take half an Angong Niuhuang pill every day for 4 weeks and Daily music scalp acupuncture treatment Receives: Drug: Angong Niuhuang Pill |
| General control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple intelligence state examination scale
MMSE
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- le zhang, Study chair, 2nd Affiliated Hospital, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731310
- Sponsor's protocol ID
- 2022-0507
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation and Evaluation of Peripheral Neuroprotective Mechanism of Amgong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05731310
- Acronym / sponsor ID
- 2022-0507
- Conditions
- Post-stroke Cognitive Impairment
- Keywords
- Post-stroke cognitive impairment;acupuncture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Feb 2023 (actual)
- 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.
Post stroke cognitive impairment (PSCI) refers to the attainment of cognitive impairment after the clinical event of stroke A range of syndromes that impede diagnostic criteria. Epidemiologically, PSCI is one of the common complications in stroke patients
Detailed description
(1) Clinical scale data of cognitive function, daily living ability of PSCI patients integrated with the research of this project using uterine Niu Huang pill combined with examined pulse music electroacupuncture
For analysis, the efficacy of PSCI patients was observed; (2) In depth studies on auditory event-related potentials of PSCI treated by uterine Niu Huang pill combined with examined pulse music electroacupuncture
The changes of serum related nerve growth factor and the relationship between each other in order to enrich / fill our province's research results in this field; (3) In key academic journals
1 high level scientific research paper published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Angong Niuhuang Pill Group | Experimental | Drug: Angong Niuhuang PillTake half an Angong Niuhuang pill every day for 4 weeks |
| Angong Niuhuang pill combined with music electroacupuncture group | Experimental | Drug: Angong Niuhuang PillTake half an Angong Niuhuang pill every day for 4 weeks and Daily music scalp acupuncture treatment |
| General control group | No intervention | –no intervention |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All were the first stroke, confirmed by head computed tomography (CT) or magnetic resonance imaging (MRI), with vital signs
- stable; (2) Those who are conscious and can cooperate with relevant treatment; (3) Montreal Cognitive Assessment Scale (MoCA) score ≤ 24 points; （4）
- The course of disease is more than 1 month, and the patient is 40-70 years old.
Key exclusion criteria (4 listed)
- People with cognitive impairment before onset; (2) There are contraindications of Angong Niuhuang Pill or electroacupuncture treatment;
- Complicated with dysfunction of heart, liver, kidney and other important organs; (4) Previous history of cerebral hemorrhage, epilepsy, brain injury, etc; (5) Before onset
- Have a history of alcohol and drug dependence; (6) The condition worsens, and new hemorrhagic or infarcted foci appear.
- -
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 |
|---|---|---|
| Angong Niuhuang PillAlso: Angong Niuhuang pill combined with music scalp acupuncture groupTake Angong Niuhuang pill half a pill/day； Angong Niuhuang pill combined with music scalp acupuncture group These operations last for 4 weeks | Drug | Angong Niuhuang Pill Group, Angong Niuhuang pill combined with music electroacupuncture group |
Primary outcome
Simple intelligence state examination scale
Time frame: up to 4 weeks
MMSE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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.
le zhang study chair
2nd Affiliated Hospital, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Angong Niuhuang Pill in people with Post-stroke Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 4 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 16 Feb 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 le zhang (86-13616511229, 2319053@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple intelligence state examination scale (time frame: up to 4 weeks). 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 16 Feb 2023.