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Study on the effect and mechanism of combination of traditional Chinese medicine and western medicine on stroke by regulating intestinal flora

Study on the effect and mechanism of combination of traditional Chinese medicine and western medicine on stroke by regulating intestinal flora

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015236
Enrollment
Unknown
Registered
2018-03-16
Start date
2018-04-01
Completion date
Unknown
Last updated
2018-03-19

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

Conditions

stroke

Interventions

control group:Bifico 4 blank capsules 2 times / day + Xinglou Chengqi Decoction 1 blank bag 2 times / day
Western medicine group:Bifico 4 capsules 2 times / day + Xinglou Chengqi Decoction 1 blank bag 2 times / day
Combine traditional Chinese and medicine treatment group:Bifico 4 capsules 2 times / day + Xinglou Chengqi Decoction 1 bag 2 times / day

Sponsors

Beijing Friendship Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria for acute ischemic stroke in Western Medicine: (1) sudden onset; (2) Focal nerve function defect; (3) The brain CT or MRI proved a new cerebral infarction. 2. The standard of diagnosis of phlegm and heat of Chinese Medicine: hemiparalysis, the deviation of the mouth, the stiff tongue, dysphasia or aphasia, hypoesthesia or anesthesia,dizziness and headache, coughing up phlegm or excessive phlegm, abdominal distention, dry stool and constipation, dark red in tongue proper,greasy and yellow fur on the tongue, wiry and rolling pulse or lateral chord slippery and large; 3. NIHSS score 4-15 in patients with moderate nerve function injury; 4. The age is 18-75 years old, and the male and female are not limited; 5. The patients will volunteer for the research and will sign the informed consent (patient or legal agent)

Exclusion criteria

Exclusion criteria: (1) Transient ischemic attack; (2) Hemorrhagic brain injury, such as cerebral hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage, etc.; (3) intracranial spaceoccupying lesions; (4) Patients with previous digestive diseases, including constipation, diarrhea, alimentary tract ulcers, gastrointestinal bleeding, ulcerative colitis, etc.; (5) In the past 1 months the patients take test medication (Bifico and xinglouchengqi decoction); (6) The patients who are allergic to the ingredients of the Experimental drug; (7) The patinets use antibiotics before and after treatment; (8) Patients with serious diseases such as heart, kidney, liver, hematopoietic system and immune system are excluded; (9) Cancer patients and patients with mental disorders.

Design outcomes

Primary

MeasureTime frame
IL-6 levels in blood;IL-10 levels in blood;TNF-a levels in blood;Separation of peripheral blood mononuclear cells by flow cytometry;Analysis of the expression of PBMC transcriptional level and screening of differentially expressed genes by the sequencing of RNA-seq transcriptome;Detection of intestinal microbes in feces by high throughput 16rRNA sequencing;NIHSS score;Barthel index score;

Countries

China

Contacts

Public ContactYingying Zhao

Beijing Friendship Hospital affiliated to Capital Medical University

zyytx@sina.com+86 18614026772

Outcome results

None listed

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