Acute IschemiaAIAINCT04528472
Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research
A study testing Acupuncture Treatment and Regular Treatment in people with Acute Ischemia, run by Shanghai University of Traditional Chinese Medicine.
Trial summary
This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Acute Ischemia
- What is being tested?
- Acupuncture Treatment and Regular Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2022
- Phase
- Interventional
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) It meets the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014"; with the support of brain CT or MRI imaging examination, the vital signs are stable, the state of consciousness is clear, and the GCS>8 points; （2）.Onset is less than 2 weeks; （3）. There is no indication for thrombolysis, or the patient do not accept thrombolysis; （4）. For moderate to severe patients, the National Institute of Health Stroke Scale (NIHSS) ≥ 4 points;（5）.Glasgow coma standard (GCS)>7 points;（6）.No serious disability before admission, and modified Rankin Scale (mRS) ≤ 3;（7）. The patient himself or his immediate family members signed the informed consent form.
Who cannot join
- (1) Cerebral hemorrhage or subarachnoid hemorrhage; (2) Cerebellar and brainstem infarction (including lacunar infarction); (3) Cerebral herniation is formed upon admission; (4) Patients with severe heart, lung, liver, and kidney diseases; (5) Severe upper gastrointestinal bleeding occurred after the onset; (6) The patient has participated in other clinical trials within the past 3 months; (7) Patients with mental illness, or those with severe cognitive impairment (MMSE score ≤9 points) (8) Those with a pacemaker, a metal foreign body at the treatment site, or a severe bleeding tendency.
- The investigator believes that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may cause other complications in the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Longhua Hospital, Shanghai University of TCM
This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI, Plasma BDNF, MMP-9 and other biomarkers.
Read the detailed description
Based on the previous work, this project optimizes the TCM Symptoms and Symptoms Scale. Through the cohort study method, 194 patients with acute ischemic stroke were evaluated for neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI. , Plasma BDNF, MMP-9 and other biomarkers, screen TCM syndromes related to stroke outcome indicators, and adopt targeted comprehensive acupuncture and moxibustion program intervention and follow-up to establish a stroke-specific intervention outcome prediction model with TCM characteristics. A curative effect evaluation system of acupuncture and moxibustion in the treatment of acute ischemic stroke is formed to provide clinical evidence.
- Conditions
- Acute Ischemia
- Being tested
- Acupuncture Treatment, Regular Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TreatmentOther
stimulate acupoints to accelerate recovery
Regular TreatmentOther
Oral Medicine and Rehabilitation Treatment
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Treatment | Experimental | Acupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment Receives: Other: Acupuncture Treatment |
| Regular Treatment | Experimental | Acupuncture Treatment Oral Medicine Rehabilitation Treatment Receives: Other: Regular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS SCALE
NIHSS was created by the National Institutes of Health and has good reliability and validity. It has been widely used to evaluate the severity and prognosis of stroke. The scale consists of consciousness, gaze, vision, facial paralysis, movement, sensation, mutual aid, language, neglect and other items, with a maximum score of 33 points.
Measured: 4 weeks
Secondary outcomes (2)
Stroke Scale of Traditional Chinese Medicine, SSTCM
SSTCM mainly includes two parts: TCM symptoms and tongue and pulse conditions. There are a total of 24 symptoms of TCM symptoms. According to their severity and impact on daily life, each item is scored into 4 grades, with 0 points for normal, 1 point for mild, 2 points for moderate, and 3 points for severe. Tongue and pulse conditions are only recorded and not scored. The total score is the sum of the scores of TCM symptoms in Part 1. The higher the score, the more severe the symptoms and the greater the impact on life.
Measured: 4 weeks
modified Barthel Index, mBI
The mBI scale is mainly used to evaluate the self-care ability of patients in daily life. It can be summarized as the patients' independent activities in an indoor environment, such as eating, dressing, and toileting, with a total of ten items. The score of each item is divided into 5 levels, the lowest is 1 and the highest is 5. The higher the level, the greater the independence, and the total score is 100 points.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute IschemiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jian pei, doctor, Study director, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528472
- Sponsor's protocol ID
- longhuaacup
- Acronym
- AIAI
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longhua Hospital, Shanghai University of TCM
- ClinicalTrials.gov ID
- NCT04528472
- Acronym / sponsor ID
- AIAI / longhuaacup
- Conditions
- Acute Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 27 Aug 2020 (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.
This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI, Plasma BDNF, MMP-9 and other biomarkers.
Detailed description
Based on the previous work, this project optimizes the TCM Symptoms and Symptoms Scale. Through the cohort study method, 194 patients with acute ischemic stroke were evaluated for neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI. , Plasma BDNF, MMP-9 and other biomarkers, screen TCM syndromes related to stroke outcome indicators, and adopt targeted comprehensive acupuncture and moxibustion program intervention and follow-up to establish a stroke-specific intervention outcome prediction model with TCM characteristics. A curative effect evaluation system of acupuncture and moxibustion in the treatment of acute ischemic stroke is formed to provide clinical evidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Treatment | Experimental | Other: Acupuncture TreatmentAcupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment |
| Regular Treatment | Experimental | Other: Regular TreatmentAcupuncture Treatment Oral Medicine Rehabilitation Treatment |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) It meets the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014"; with the support of brain CT or MRI imaging examination, the vital signs are stable, the state of consciousness is clear, and the GCS>8 points; （2）.Onset is less than 2 weeks; （3）. There is no indication for thrombolysis, or the patient do not accept thrombolysis; （4）. For moderate to severe patients, the National Institute of Health Stroke Scale (NIHSS) ≥ 4 points;（5）.Glasgow coma standard (GCS)>7 points;（6）.No serious disability before admission, and modified Rankin Scale (mRS) ≤ 3;（7）. The patient himself or his immediate family members signed the informed consent form.
Key exclusion criteria (2 listed)
- (1) Cerebral hemorrhage or subarachnoid hemorrhage; (2) Cerebellar and brainstem infarction (including lacunar infarction); (3) Cerebral herniation is formed upon admission; (4) Patients with severe heart, lung, liver, and kidney diseases; (5) Severe upper gastrointestinal bleeding occurred after the onset; (6) The patient has participated in other clinical trials within the past 3 months; (7) Patients with mental illness, or those with severe cognitive impairment (MMSE score ≤9 points) (8) Those with a pacemaker, a metal foreign body at the treatment site, or a severe bleeding tendency.
- The investigator believes that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may cause other complications in the patient.
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 |
|---|---|---|
| Acupuncture Treatmentstimulate acupoints to accelerate recovery | Other | Acupuncture Treatment |
| Regular TreatmentOral Medicine and Rehabilitation Treatment | Other | Regular Treatment |
Primary outcome
NIHSS SCALE
Time frame: 4 weeks
NIHSS was created by the National Institutes of Health and has good reliability and validity. It has been widely used to evaluate the severity and prognosis of stroke. The scale consists of consciousness, gaze, vision, facial paralysis, movement, sensation, mutual aid, language, neglect and other items, with a maximum score of 33 points.
2 secondary outcomes
Stroke Scale of Traditional Chinese Medicine, SSTCM
Time frame: 4 weeks
modified Barthel Index, mBI
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
jian pei, doctor study director
Longhua Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Treatment and Regular Treatment in people with Acute Ischemia, run by Shanghai University of Traditional Chinese Medicine.
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 2 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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 qinhui fu, doctor (008613795396770, ff777315@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS SCALE (time frame: 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 27 Aug 2020.