Overview

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

Status:
Not yet recruiting
Trial end date:
2023-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ying Gao
Collaborator:
Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing
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.