Back to resultsEvidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke, neurologic impairment, integrative therapy, Chinese herbs, prospective randomized double-blind controlled trial
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.
Sites / Locations
- Guangdong Provincial Hospital of Chinese medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Integrative Treatment Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Proportion of Patients Independent
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
Activities of Daily Living
The Barthel Index score ranges from 0 (worst score) to 100 (best score).
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．
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.
Proportion of complications during hospitalization
The complications include hemorrhagic transformation, pulmonary infection, urinary tract infection, Gastrointestinal hemorrhage, etc.
Full Information
NCT ID
NCT04199455
First Posted
December 8, 2019
Last Updated
December 12, 2019
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04199455
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute ischemic stroke, neurologic impairment, integrative therapy, Chinese herbs, prospective randomized double-blind controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrative Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)
Other Intervention Name(s)
EPACH Recipe Granules + NQABC Recipe Granules
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Recipe Simulators
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the change in the NIHSS scores from baseline to 15 days in the two groups.
Description
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Time Frame
Baseline and 15 days.
Secondary Outcome Measure Information:
Title
Proportion of Patients Independent
Description
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.
Title
Activities of Daily Living
Description
The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Time Frame
30 days and 90 days after symptom onset.
Title
Stoke Syndrome Factor Evaluation Scale
Description
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.
Title
Patient Reported Outcome (PRO) Scale of Stroke
Description
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
Title
Proportion of complications during hospitalization
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanqi Zhao, MD
Phone
+8613922137130
Email
tcm2008@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Min Zhao, MD
Phone
+8615989184470
Email
cassiesandra@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yefeng Cai, MD
Organizational Affiliation
Guangzhou University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yefeng Cai, MD
Phone
+8613631333842
Email
caiyefeng@126.com
First Name & Middle Initial & Last Name & Degree
Yuanqi Zhao, Yuanqi
Phone
+8613922137130
Email
tcm2008@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke
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