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Clinical Observation and Mechanism Study of Jianling Decoction in Treating the Syndrome of Wind Yang Floating Upwards Type Ischemic Stroke Based on the 'Gut Microbiota-Gut-Brain' Axis

Clinical Observation and Mechanism Study of Jianling Decoction in Treating the Syndrome of Wind Yang Floating Upwards Type Ischemic Stroke Based on the 'Gut Microbiota-Gut-Brain' Axis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084388
Enrollment
Unknown
Registered
2024-05-15
Start date
2024-05-16
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

Control group:Dibenzoylmethane Sodium Chloride Injection (produced by Shiyao Group Enbipu Pharmaceutical Co., Ltd., National Medical Products Administration Approval No. H20100041), 1 bottle/time, int
treatment group:In the treatment group, in addition to the control group, Jianling Decoction is administered. The specific composition of the Chinese herbal decoction is as follows: 30g Dioscorea oppo

Sponsors

Huizhou Hospital of Guangzhou University of Chinese Medicine (Huizhou Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Conforming to the IS Western medical diagnostic criteria; (2) Conforming to the Traditional Chinese Medicine diagnostic criteria for the syndrome of wind yang upward disturbance in stroke patients; (3) Falling within the category of stroke in the meridian-collateral system, namely, with no obvious abnormalities in consciousness, and scoring 0 points in items 1a, 1b, and 1c of the National Institutes of Health Stroke Scale (NIHSS); (4) First onset of the disease, and the time from onset to admission being between 6 to 72 hours; (5) Stable vital signs, suitable for standardized hospitalization for 14 days; (6) TOAST classification belonging to one of the following types: large-artery atherosclerosis type, cardioembolic type, or small-artery occlusion type; (7) Severity grading of NIHSS score falls into mild, moderate, or moderate-severe stroke, meaning NIHSS score at admission is 1 point < NIHSS score = 20 points; (8) Voluntary signing of informed consent form.

Exclusion criteria

Exclusion criteria: (1) Undergoing intravenous thrombolysis treatment; (2) Undergoing endovascular intervention treatment; (3) Patients with reversible neurological deficits; (4) Ischemic stroke caused by congenital cerebral vascular malformation, cranial trauma, cranial tumors, or other etiologies; (5) Patients with severe liver, heart, lung, kidney dysfunction, or malignant tumors and hematologic disorders; (6) Patients with severe psychiatric disorders, such as severe depression or mania; (7) Patients with drug allergies.

Design outcomes

Primary

MeasureTime frame
National Institute of Health stroke scale;diversity, abundance of intestinal flora;

Secondary

MeasureTime frame
Modified Rankin Scale;Modified Barthel Index;Fugl-Meyer assessment scale;Traditional Chinese Medicine syndrome score;

Countries

China

Contacts

Public ContactLin Ling

Huizhou Hospital of Guangzhou University of Chinese Medicine (Huizhou Hospital of Traditional Chinese Medicine)

linlingtcm520@163.com+86 182 0061 5798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026