Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS) (PHYSIS)

Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS): A Non-randomized, Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke, Acute
• Intervention / Treatment: Drug: Yiqihuayu Decotion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Shi Shi; Phone Number: 13021651656; Email: xinyishi@bucm.edu.cn
• Study Contact Backup: Name: Gao; Phone Number: 13366275973; Email: gaoying973@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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)	Drug: Yiqihuayu Decotion; Per os, twice a day, for 7 days.
No Intervention: Control group; No Intervention: Control group Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (e.g. antiplatelet drugs and statins)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days, 8 days, 9 days, 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 day, 3 days, 9 days
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).	1 day, 30 days

Collaborators and Investigators

• Sponsor: Ying Gao
• Collaborators: Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 24, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2018YFC1705001-05-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No