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

Sponsor

Ying Gao (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05560152

Collaborator

Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing (Other)

Enrollment

Arms

5.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke, Acute	Drug: Yiqihuayu Decotion	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Differences in Caffeic acid, Amygdalin, Paeoniflorin between experimental group and control group. [3 days, 8 days, 9 days, 10 days]
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 [1 day, 3 days, 9 days]
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 [1 day, 30 days]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ying Gao
Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying Gao, Professor, Dongzhimen Hospital, Beijing

ClinicalTrials.gov Identifier:

NCT05560152

Other Study ID Numbers:

2018YFC1705001-05-03

First Posted:

Sep 29, 2022

Last Update Posted:

Sep 29, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2022