A Phase 2/3 interventional study of Yiqihuayu Decotion in Ischemic Stroke, Acute, sponsored by Ying Gao. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Ying Gao · Phase 2/3, Interventional, and Basic science
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →Ying Gao is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
No Intervention: Control group Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (e.g. antiplatelet drugs and statins)
Per os, twice a day, for 7 days.
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ying Gao