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Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke

NCT ID: NCT04199455

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2021-08-30

Brief Summary

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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

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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

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Ischemic Stroke

Keywords

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acute ischemic stroke neurologic impairment integrative therapy Chinese herbs prospective randomized double-blind controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Integrative Treatment Group

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.

Group Type EXPERIMENTAL

Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)

Intervention Type DRUG

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.

Control Group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Other Intervention Names

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EPACH Recipe Granules + NQABC Recipe Granules Recipe Simulators

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yefeng Cai

Director of Encephalopathy Center of Guangdong Provincial Hospital of Chinese Medcicine, Professor, Chief Physician, Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yefeng Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou University of Traditional Chinese Medicine

Locations

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Guangdong Provincial Hospital of Chinese medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuanqi Zhao, MD

Role: CONTACT

Phone: +8613922137130

Email: [email protected]

Min Zhao, MD

Role: CONTACT

Phone: +8615989184470

Email: [email protected]

Facility Contacts

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Yefeng Cai, MD

Role: primary

Yuanqi Zhao, Yuanqi

Role: backup

Other Identifiers

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2018YFC1705002

Identifier Type: -

Identifier Source: org_study_id