Ischemic StrokePhase 4NCT04199455
Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke
A Phase 4 study testing Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules) in people with Ischemic Stroke, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The main purpose of this trial is to determine whether Chinese medicine (CM) for eliminating phlegm and clearing heat (EPACH) recipe continuously with nourishing Qi and activating blood circulation (NQABC) recipe, oral within 72 hours of symptom onset, improves the 15-day neurologicl deficits in participants with… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2019to 30 Aug 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute disabling ischemic stroke (4≤ NIHSS score ≤25 at the time of randomization) that can be treated with study drug within 72 hours of symptoms onset. Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI) or computer tomography (CT).
- Adult subjects (male or female ≥ 40 years and ≤ 80 years)
- Diagnosis of phlegm-dampness syndrome with manifestation of heat (the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥2 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke.
- Patient or legally authorized representative has signed informed consent.
Who cannot join
- Planned or already receiving intravenous thrombolysis or endovascular treatment (intravascular mechanical thrombectomy, intra-arterial thrombolysis and angioplasty).
- Patients who have received other traditional Chinese Medicine Decoctions (Granules) and Chinese patent medicines Treatment for stroke.
- Confirmed secondary stroke caused by tumors, brain trauma, hematological diseases, infectious diseases, hereditary diseases, rheumatic immune diseases, etc
- modified Rankin Scale (mRS) Score > 2 at randomization (pre-morbid historical assessment).
- Other conditions that lead to motor dysfunction (i.n., severe osteoarthritis, rheumatoid arthritis, gouty arthritis, etc).
- Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal)
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- Severe non-cardiovascular comorbidity with life expectancy < 3 months.
- Complicated with other diseases that limited the evaluation of neurological function or affect the follow-up of patients.
- Known to be pregnant or breastfeeding.
- Currently receiving an investigational drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Chinese medicine
Guangzhou, Guangdong, 510120
Yefeng Cai, MD, +8613631333842, caiyefeng@126.com
Yuanqi Zhao, Yuanqi, +8613922137130, tcm2008@126.com
About this study
Official title: The Differentiation and Treatment Scheme of TCM Key Syndromes for the Treatment of Acute Disabling Ischemic Stroke: a Randomized, Double-Blind, Placebo-Controlled Multicenter Trial
The main purpose of this trial is to determine whether Chinese medicine (CM) for eliminating phlegm and clearing heat (EPACH) recipe continuously with nourishing Qi and activating blood circulation (NQABC) recipe, oral within 72 hours of symptom onset, improves the 15-day neurologicl deficits in participants with acute ischemic stroke.
Read the detailed description
Many years of clinical practice experience has found that Chinese medicine (CM) for EPACH recipe continuously with NQABC recipe can be beneficial to the recovery of neurological function in the early stage of ischemic stroke. However, there is lack of high-quality evidence of its efficacy for acute ischemic stroke currently. The primary hypothesis of this trial is that Chinese herbal therapeutic regimen of EPACH+NQABC combined with guideline-based standard treatment will improve the 15-day neurological deficits in patients with acute ischemic stroke (AIS). Totally 500 participants will be randomized to the integrative treatment group treated with EPACH + NQABC recipes granules in addition to guideline-based standard treatment or the control group with placebo and guideline-based standard treatment equally for 15 days. All patients will have a National Institutes of Health Stroke Scale (NIHSS) entry score of 4-25. Patients in each group will be treated according to guideline-based standard treatment, but patients who have received or intend to undergo intravenous thrombolysis or endovascular interventions (including intravascular mechanical thrombectomy, arterial thrombolysis, angioplasty) are excluded. The primary outcome will be determined at 15 days, and all the participants will be followed up for 90 days.
- Conditions
- Ischemic Stroke
- Being tested
- Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules), Placebo
- Keywords
- acute ischemic stroke, neurologic impairment, integrative therapy, Chinese herbs, prospective randomized double-blind controlled trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)Drug
Also called EPACH Recipe Granules + NQABC Recipe Granules
Patients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018.
Route of administration: oral.
Dose regimen:
Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of EPACH recipe granules, dissolved with 200ml of boiled water, twice a day.
Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of NQABC recipe granules, dissolved with 200ml of boiled water, twice a day.
PlaceboDrug
Also called Recipe Simulators
Patients randomly assigned to the intervention group will receive recipe simulators as placebo. EPACH and NQABC granules and recipe simulators are indistinguishable, identical in size, shape, color, appearance. Placebo is no decocting granules contain 5% original formula, 20% bitter gourd extract, 75% dextrin, and caramel color. Those who are assigned to the control group will be given placebo and guideline-based standard stroke treatment.
Route of administration: oral.
Dose regimen:
Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of recipe simulator, dissolved with 200ml of boiled water, twice a day.
Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of recipe simulator, dissolved with 200ml of boiled water, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Treatment Group | Experimental | Patients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018. Receives: Drug: Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules) |
| Control Group | Placebo comparator | Patients randomly assigned to the control group will receive recipe simulators as placebo, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the change in the NIHSS scores from baseline to 15 days in the two groups.
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Measured: Baseline and 15 days.
Secondary outcomes (5)
Proportion of Patients Independent
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Measured: 30 days and 90 days after symptom onset.
Activities of Daily Living
The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Measured: 30 days and 90 days after symptom onset.
Stoke Syndrome Factor Evaluation Scale
The Stroke Syndrome Factor Evaluation Scale ( a preliminary scale) is formed based on item response theory． It contains 76 items，among which there are 8 items of endogenous wind syndrome，24 items of endogenous fire syndrome, 12 items of phlegm-dampness syndrome, 8 items of blood stasis syndrome, 15 items of Qi deficiency syndrome, and 9 items of Yin deficiency syndrome．
Measured: 5 days and 15 days after randomization.
Patient Reported Outcome (PRO) Scale of Stroke
PRO score ranges from 36 (best score) to 180 (worst score). PRO consists of four dimensions including the influence on physical, emotional, and social functioning, as well as the overall satisfaction with treatment.
Measured: 15 days after randomization
Proportion of complications during hospitalization
The complications include hemorrhagic transformation, pulmonary infection, urinary tract infection, Gastrointestinal hemorrhage, etc.
Measured: During the period of hospitalization, an average of 10 to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start4 Dec 2019
- Primary completion30 May 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yefeng Cai, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Yefeng Cai, MD, Principal investigator, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199455
- Sponsor's protocol ID
- 2018YFC1705002
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differentiation and Treatment Scheme of TCM Key Syndromes for the Treatment of Acute Disabling Ischemic Stroke: a Randomized, Double-Blind, Placebo-Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT04199455
- Acronym / sponsor ID
- 2018YFC1705002
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, neurologic impairment, integrative therapy, Chinese herbs, prospective randomized double-blind controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 16 Dec 2019 (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.
The main purpose of this trial is to determine whether Chinese medicine (CM) for eliminating phlegm and clearing heat (EPACH) recipe continuously with nourishing Qi and activating blood circulation (NQABC) recipe, oral within 72 hours of symptom onset, improves the 15-day neurologicl deficits in participants with acute ischemic stroke.
Detailed description
Many years of clinical practice experience has found that Chinese medicine (CM) for EPACH recipe continuously with NQABC recipe can be beneficial to the recovery of neurological function in the early stage of ischemic stroke. However, there is lack of high-quality evidence of its efficacy for acute ischemic stroke currently. The primary hypothesis of this trial is that Chinese herbal therapeutic regimen of EPACH+NQABC combined with guideline-based standard treatment will improve the 15-day neurological deficits in patients with acute ischemic stroke (AIS). Totally 500 participants will be randomized to the integrative treatment group treated with EPACH + NQABC recipes granules in addition to guideline-based standard treatment or the control group with placebo and guideline-based standard treatment equally for 15 days. All patients will have a National Institutes of Health Stroke Scale (NIHSS) entry score of 4-25. Patients in each group will be treated according to guideline-based standard treatment, but patients who have received or intend to undergo intravenous thrombolysis or endovascular interventions (including intravascular mechanical thrombectomy, arterial thrombolysis, angioplasty) are excluded. The primary outcome will be determined at 15 days, and all the participants will be followed up for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Treatment Group | Experimental | Drug: Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)Patients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018. |
| Control Group | Placebo comparator | Drug: PlaceboPatients randomly assigned to the control group will receive recipe simulators as placebo, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute disabling ischemic stroke (4≤ NIHSS score ≤25 at the time of randomization) that can be treated with study drug within 72 hours of symptoms onset. Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI) or computer tomography (CT).
- Adult subjects (male or female ≥ 40 years and ≤ 80 years)
- Diagnosis of phlegm-dampness syndrome with manifestation of heat (the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥2 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke.
- Patient or legally authorized representative has signed informed consent.
Key exclusion criteria (10 listed)
- Planned or already receiving intravenous thrombolysis or endovascular treatment (intravascular mechanical thrombectomy, intra-arterial thrombolysis and angioplasty).
- Patients who have received other traditional Chinese Medicine Decoctions (Granules) and Chinese patent medicines Treatment for stroke.
- Confirmed secondary stroke caused by tumors, brain trauma, hematological diseases, infectious diseases, hereditary diseases, rheumatic immune diseases, etc
- modified Rankin Scale (mRS) Score > 2 at randomization (pre-morbid historical assessment).
- Other conditions that lead to motor dysfunction (i.n., severe osteoarthritis, rheumatoid arthritis, gouty arthritis, etc).
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 |
|---|---|---|
| Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)Also: EPACH Recipe Granules + NQABC Recipe GranulesPatients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018. Route of administration: oral. Dose regimen: Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of EPACH recipe granules, dissolved with 200ml of boiled water, twice a day. Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of NQABC recipe granules, dissolved with 200ml of boiled water, twice a day. | Drug | Integrative Treatment Group |
| PlaceboAlso: Recipe SimulatorsPatients randomly assigned to the intervention group will receive recipe simulators as placebo. EPACH and NQABC granules and recipe simulators are indistinguishable, identical in size, shape, color, appearance. Placebo is no decocting granules contain 5% original formula, 20% bitter gourd extract, 75% dextrin, and caramel color. Those who are assigned to the control group will be given placebo and guideline-based standard stroke treatment. Route of administration: oral. Dose regimen: Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of recipe simulator, dissolved with 200ml of boiled water, twice a day. Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of recipe simulator, dissolved with 200ml of boiled water, twice a day. | Drug | Control Group |
Primary outcome
Comparison of the change in the NIHSS scores from baseline to 15 days in the two groups.
Time frame: Baseline and 15 days.
The NIHSS score ranges from 0 (best score) to 42 (worst score).
5 secondary outcomes
Proportion of Patients Independent
Time frame: 30 days and 90 days after symptom onset.
Activities of Daily Living
Time frame: 30 days and 90 days after symptom onset.
Stoke Syndrome Factor Evaluation Scale
Time frame: 5 days and 15 days after randomization.
Patient Reported Outcome (PRO) Scale of Stroke
Time frame: 15 days after randomization
Proportion of complications during hospitalization
Time frame: During the period of hospitalization, an average of 10 to 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Yefeng Cai, MD principal investigator
Guangzhou University of Traditional Chinese Medicine
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 Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules) in people with Ischemic Stroke, run by Guangzhou University of Traditional Chinese 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 4 inclusion and 10 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 Dec 2019. 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. Some participants in this study may receive a placebo. 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 Yuanqi Zhao, MD (+8613922137130, tcm2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change in the NIHSS scores from baseline to 15 days in the two groups. (time frame: Baseline and 15 days.). 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 Dec 2019.