Skip to content

Based on 16S rDNA sequencing technology and metabolomics, investigating the clinical efficacy of Qingre Kaiqiao decoction for ischemic stroke treatment.

Based on 16S rDNA sequencing technology and metabolomics, investigating the clinical efficacy of Qingre Kaiqiao decoction for ischemic stroke treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000015
Enrollment
Unknown
Registered
2026-01-04
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-12

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:Conventional Western medical treatment for ischemic stroke includes antiplatelet aggregation, anticoagulation, lipid regulation and plaque stabilization, neuroprotection, etc.
for patients with other non-severe underlying diseases, routine symptomatic treatment is provided.
Treatment group:In addition to the conventional Western medicine treatment, the Qingre Kaiqiao decoction was administered at a dose of 1 per day, boiled in 200ml of water, and taken in two divided dos

Sponsors

Beijing University of Chinese Medicine Oriental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
41 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for acute ischemic stroke; (2) Meets the diagnostic criteria for stroke disease with exuberant heat inside and phlegm and blood stasis obstructing the meridians; (3) Age 41 to 80 years, both male and female; (4) First onset; (5) Time since onset =72 hours; (6) NIHSS score: 2 = score =15; (7) Informed and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Intracranial space-occupying lesions, TIA, cerebral hemorrhage, subarachnoid hemorrhage, and other cerebrovascular diseases; (2) Post-stroke mental status disorders, such as somnolence, coma, or severe aphasia, making it impossible to answer questions or follow instructions independently; (3) Treatment with traditional Chinese medicine formulations such as Xuesaitong, Xingnaojing, and Danshen injection; (4) Preparation for or having undergone thrombolysis or mechanical thrombectomy; (5) Presence of gastrointestinal organic lesions, such as gastrointestinal bleeding or ulcers, or a tendency to bleed; (6) Concurrent severe primary diseases, such as hepatic or renal insufficiency, cardiopulmonary failure, or hematological disorders; (7) Presence of mental disorders that prevent cooperation with the trial; (8) History of suspected or confirmed drug or alcohol abuse; (9) Pregnant or breastfeeding women, or those with plans for pregnancy in the near future; (10) Allergy to this drug or a history of allergic constitution; (11) Poor compliance, inability to take medication on time, or participation in other drug clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
Parabacteroides;Short-Chain Fatty Acids;D-lactic acid;Trimethylamine N-oxide;Total Cholesterol;Triglyceride;Interleukin-6;Interleukin-1ß;Interleukin-8;Interleukin-10;Tumor Necrosis Factor-alpha;High-sensitivity C-reactive protein;Neurological Deficit Score (NIHSS);TCM syndrome score;Alcaligenes;Enterobacter;

Secondary

MeasureTime frame
Modified Rankin Scale (mRS scoring);Activities of Daily Living (ADL) Assessment;Activities of Daily Living (ADL) Barthel Index;

Countries

China

Contacts

Public ContactLiu Xue Mei

Beijing University of Chinese Medicine Oriental Hospital

liuxuemeitcm@163.com13810150666

Outcome results

None listed

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