Back to resultsAnalyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS) (PHYSIS)
Primary Purpose
Ischemic Stroke, Acute
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Yiqihuayu Decotion
Sponsored by
About this trial
This is an interventional basic science trial for Ischemic Stroke, Acute
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Acute ischemic stroke;
- Symptom onset of 4 to 6 days;
- 40 ≤ age ≤ 80 years;
- Be conscious and able to cooperate with clinical information gatherers;
- Patient or legally authorized representative has signed informed consent.
Exclusion Criteria:
- Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
- Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
- Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- 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);
- Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
- Other conditions that render outcomes or follow-up unlikely to be assessed;
- Known to be pregnant or breastfeeding;
- Participating in another clinical study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Experimental: Experimental group Subjects will receive Yiqihuayu Decotion, combined with guidelines-based standard care. Interventions: Drugs: Yiqihuayu Decotion Other: Standard care (e.g. antiplatelet drugs and statins)
No Intervention: Control group Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (e.g. antiplatelet drugs and statins)
Outcomes
Primary Outcome Measures
Differences in Caffeic acid, Amygdalin, Paeoniflorin between experimental group and control group.
Differences in the content of Caffeic acid, Amygdalin, Paeoniflorin in plasma and urine samples between experimental group and control group.
Secondary Outcome Measures
The change of neurological deficits
The change of neurological deficits is measured by the change of National Institute of Health Stroke Scale (NIHSS) score, ranging from 0 (best score) to 42 (worst score).
The proportion of life dependency
The proportion of life dependency is defined as Modified Rankin Scale (mRS) score 0-2. The mRS score ranges from 0 (best score) to 6 (worst score).
Full Information
NCT ID
NCT05560152
First Posted
September 15, 2022
Last Updated
September 24, 2022
Sponsor
Ying Gao
Collaborators
Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05560152
Brief Title
Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS)
Acronym
PHYSIS
Official Title
Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS): A Non-randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ying Gao
Collaborators
Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Yiqihuayu Decotion for acute ischemic stroke. The trial is a non-randomized, controlled clinical trial.
Detailed Description
Yiqihuayu Decotion is effective for acute ischemic stroke clinically, but there is lack of sufficient and reasonable explanation of its intervention effects currently. In order to further clarify the main pharmacodynamic substances of Yiqihuayu Decotion in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, controlled clinical trial. The primary hypothesis is that, compared with the control group, Yiqihuayu Decotion will produce serial changes in plasma metabolites at pre-dose and 9 days, as well as urine metabolites at pre-dose, 8 days, 9 days and 10 days. The serial changes may be the potential support to explain the intervention effect of Yiqihuayu Decotion. After enrollment, all participants will undergo a 2-day Traditional Chinese Medcine washout period to ensure that the results of pharmacodynamic substances will not be disturbed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental: Experimental group Subjects will receive Yiqihuayu Decotion, combined with guidelines-based standard care.
Interventions:
Drugs: Yiqihuayu Decotion Other: Standard care (e.g. antiplatelet drugs and statins)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No Intervention: Control group Subjects will receive guidelines-based standard care.
Interventions:
Other: Standard care (e.g. antiplatelet drugs and statins)
Intervention Type
Drug
Intervention Name(s)
Yiqihuayu Decotion
Intervention Description
Per os, twice a day, for 7 days.
Primary Outcome Measure Information:
Title
Differences in Caffeic acid, Amygdalin, Paeoniflorin between experimental group and control group.
Description
Differences in the content of Caffeic acid, Amygdalin, Paeoniflorin in plasma and urine samples between experimental group and control group.
Time Frame
3 days, 8 days, 9 days, 10 days
Secondary Outcome Measure Information:
Title
The change of neurological deficits
Description
The change of neurological deficits is measured by the change of National Institute of Health Stroke Scale (NIHSS) score, ranging from 0 (best score) to 42 (worst score).
Time Frame
1 day, 3 days, 9 days
Title
The proportion of life dependency
Description
The proportion of life dependency is defined as Modified Rankin Scale (mRS) score 0-2. The mRS score ranges from 0 (best score) to 6 (worst score).
Time Frame
1 day, 30 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:
Diagnosis of Acute ischemic stroke;
Symptom onset of 4 to 6 days;
40 ≤ age ≤ 80 years;
Be conscious and able to cooperate with clinical information gatherers;
Patient or legally authorized representative has signed informed consent.
Exclusion Criteria:
Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
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);
Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
Other conditions that render outcomes or follow-up unlikely to be assessed;
Known to be pregnant or breastfeeding;
Participating in another clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi Shi
Phone
13021651656
Email
xinyishi@bucm.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Gao
Phone
13366275973
Email
gaoying973@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS)
We'll reach out to this number within 24 hrs