Spatiotemporal Evolution of Traditional Chinese Medicine Mechanisms in Acute Ischemic Stroke Treated With Dengzhan Xixin and Dengzhan Shengmai
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 358
Study Overview
Brief Summary
To integrate large-scale RCT data on clinical symptoms, TCM syndromes, prognosis, and multi-omics profiles, construct a spatiotemporal dynamic network for disease-syndrome evolution of acute ischemic stroke (AIS) in the acute and recovery phases, evaluate the efficacy and safety of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS, and provide evidence for precise syndrome differentiation and individualized therapy.Secondary Objective:To investigate the optimal time window and key intervention targets of sequential treatment with Erigeron breviscapus-Dengzhan Shengmai for AIS.
Detailed Description
This study is a randomized (1:1), double - blind, multicenter, parallel - controlled clinical trial. It plans to recruit 358 patients with acute ischemic stroke (AIS). The research period is 3 months. After the blind is unmasked in the third month, an exploratory clinical study will be carried out and the patients will be observed for 6 months. The purpose of the study is to explore the spatio - temporal evolution law, efficacy, and safety of the sequential treatment of AIS with "Erigeron breviscapus - Dengzhan Shengmai". After all the selected patients sign the informed consent form and meet the inclusion/exclusion criteria, they will be randomly assigned to the experimental group or the control group at a ratio of 1:1 through the central randomization system (IWRS):
Experimental group:
Acute phase (0 - 7 days after onset): 40 mL of Erigeron breviscapus injection diluted with 250 mL of normal saline, administered by intravenous drip once a day; Recovery phase (8 - 90 days): 2 capsules of Dengzhan Shengmai capsules (0.18 g per capsule), taken orally three times a day.
Control group:
Acute phase (0 - 7 days after onset): 250 mL of normal saline, administered by intravenous drip once a day; Recovery phase (8 - 90 days): 2 placebo capsules (starch, 0.18 g per capsule), taken orally three times a day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Meeting the diagnostic criteria for acute ischemic stroke in accordance with the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2023
- •Within 48 hours after the first onset
- •National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 25 points
- •Voluntarily signed informed consent.
Exclusion Criteria
- •Pre-stroke modified Rankin Scale (mRS) score ≥ 2
- •Patients with transient ischemic attack (TIA), complicated with cerebral hemorrhage or subarachnoid hemorrhage
- •patients with brain tumor, Alzheimer's disease, psychosis, or a confirmed diagnosis of dementia
- •Patients undergoing endovascular thrombectomy
- •Patients with severe cardiac diseases such as valvular heart disease, infective endocarditis, myocardial infarction, heart failure, severe hepatic or renal insufficiency, respiratory failure, malignant tumor, or massive gastrointestinal hemorrhage
- •Patients who have used any preparations containing the same ingredients as the study drug (e.g., Erigeron breviscapus, ginseng, dwarf lilyturf tuber, schisandra chinensis, etc.) within the past 2 weeks
- •Patients with a history of allergy to the study drug or preparations containing the same ingredients
- •Pregnant or lactating women
- •Patients judged by the investigators as unsuitable for participation in this trial.
Investigators
Cheng xiao
Senior Research Fellow
Guangdong Provincial Hospital of Traditional Chinese Medicine