Dongzhimen Hospital, Beijing University of Chinese Medicine
Richmond, British Columbia, V7E 6J1, Canada
NCT Number: NCT07163702
This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 2
Richmond, British Columbia, V7E 6J1, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Other names: Guidelines-based standard care
Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.
Other names: Guidelines-based standard care
Time frame: Baseline and Day 14.
The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups.
Time frame: Day 30, Day 60 and Day 90.
The proportions of patients with modified Rankin Scale (mRS) ≤ 2 or mRS ≤ 1 will be analyzed between groups.
Time frame: Day 7, day 30, day 60, day 90.
The change of NIHSS score will be analyzed at days 7, 30, 60, and 90.
Time frame: day 7, day 14, day 30, day 60, day 90.
The proportion of patients with Barthel Index score ≥ 95 or ≥ 75 will be analyzed at days 7, 14, 30, 60, and 90.
Time frame: day 7, day 14, day 30, day 60, day 90.
The change of EQ-5D score from baseline to days 7, 14, 30, 60, and 90 will be analyzed between groups.
Time frame: day 7, day 14, day 30, day 60, day 90.
The incidence of new cardiovascular events will be analyzed at day 7, 14, 30, 60, and 90.
Contact information is provided by the study sponsor or research team.
Dongzhimen Hospital, Beijing
Other
Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke (EXACT): a Multi-center, Randomized, Double-blinded, Dose-exploration Ⅱa Trial
Acronym: EXACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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