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

NCT05560152 | Unknown Phase 2

• 1 other identifier: 2018YFC1705001-05-03
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change of neurological deficits

  1 day, 3 days, 9 days

• The proportion of life dependency

  1 day, 30 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No Intervention: Control group Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (e.g. antiplatelet drugs and statins)

Interventions

Yiqihuayu Decotion DRUG

Per os, twice a day, for 7 days.

Experimental group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Acute ischemic stroke;
• Symptom onset of 4 to 6 days;
• ≤ age ≤ 80 years;
• Be conscious and able to cooperate with clinical information gatherers;
• Patient or legally authorized representative has signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ying Gao: lead
• Dongzhimen Hospital, Beijing: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shi Shi

CONTACT

13021651656; xinyishi@bucm.edu.cn

Gao

CONTACT

13366275973; gaoying973@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 29, 2022
• Study Start: September 25, 2022
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share