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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
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.
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.
Guangdong Provincial Hospital of Chinese medicine
Guangzhou, Guangdong, China
RECRUITINGComparison 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).
Time frame: Baseline and 15 days.
Proportion of Patients Independent
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 15 days after randomization
Proportion of complications during hospitalization
The complications include hemorrhagic transformation, pulmonary infection, urinary tract infection, Gastrointestinal hemorrhage, etc.
Time frame: During the period of hospitalization, an average of 10 to 15 days
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