Clinical trial NCT04199455: Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke
neurologic impairment
integrative therapy
Chinese herbs
prospective randomized double-blind controlled trial
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the change in the NIHSS scores from baseline to 15 days in the two groups.
timeFrame: Baseline and 15 days.
Secondary outcomes:
measure: Proportion of Patients Independent
timeFrame: 30 days and 90 days after symptom onset.
measure: Activities of Daily Living
timeFrame: 30 days and 90 days after symptom onset.
measure: Stoke Syndrome Factor Evaluation Scale
timeFrame: 5 days and 15 days after randomization.
measure: Patient Reported Outcome (PRO) Scale of Stroke
timeFrame: 15 days after randomization
measure: Proportion of complications during hospitalization
timeFrame: During the period of hospitalization, an average of 10 to 15 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese medicine
state: Guangdong
Study officials:
affiliation: Guangzhou University of Traditional Chinese Medicine
name: Yefeng Cai, MD
role: PRINCIPAL_INVESTIGATOR
References: