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

Ying Gao15 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ischemic Stroke, Acute

Interventions

Yiqihuayu DecotionDRUG

Per os, twice a day, for 7 days.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 days, 8 days, 9 days, 10 days

Secondary Outcomes

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).

Time frame: 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).

Time frame: 1 day, 30 days

Central Contacts

Shi Shi

CONTACT

13021651656 xinyishi@bucm.edu.cn

Gao

CONTACT

13366275973 gaoying973@126.com

Data from ClinicalTrials.gov

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