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Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction

Study of Effects and Mechanisms of Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02846207
Enrollment
360
Registered
2016-07-27
Start date
2016-03-31
Completion date
2019-12-31
Last updated
2018-02-12

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

Conditions

Cerebral Infarction

Keywords

cerebral infarction, syndrome of qi deficiency and blood stasis, Buyanghuanwu decoction, clinical effects and mechanisms

Brief summary

This clinical research is based on the fundamentals of using Chinese medicine, which will improve Qi and promote blood circulation, to treat patients in the recuperating stages of cerebral infarction with deficiency in Qi and blood stasis syndrome. By assimilating Chinese medical theory, this research aims to study the biological basics of the stroke and the cause for the deficiency in Qi and blood stasis syndrome; explore the therapeutic mechanism of the treatment methods; as well as ascertaining the relationship between Qi, blood and blood vessels.

Detailed description

Cerebral infarction, or ischemic stroke, is a common yet challenged illness with four telltale signs (high occurrence rate, high incapacitate rate, high mortality rate, and high recurrence rate), posing not only a threat to a man's health and life, but also imposing a burden to the society and his loved ones. As such, seeking a cure has always been the hot topic in this field of research. With regard to the illness' high incapacitate and recurrence rates, it has become apparent that the treatment methods used in the recuperating stages of stroke are very significant to the patient, allowing him the chance to regain his health and increase his quality of life. In Chinese medical terms, the pathogenesis key of stroke is a deficiency in the vitals of the body coupled with superficiality extremities. As such, in the recuperating stage of the stroke, a lack of Qi accompanied with blood stasis syndrome is often observed. Hence, improving Qi and promoting blood circulation is essential during treatment. Research further supports that this treatment method is highly effective in treating cerebral infarction, but the mechanism involved is still incomprehensible, largely due to the fact that the pathology of cerebral infraction is highly complicated, and that Chinese medicine is multi-leveled, multi-channeled, with multi-targets. To further study the relationship of Qi and blood in cerebral infraction, patients in the recuperating stages with deficiency in Qi and blood stasis underwent observation in a double blind clinical research. The patients were sorted in random into groups: improving Qi group, promoting blood circulation group, improving Qi and promoting blood circulation group, and the control group. Each group of patients was given the standard Western medicine treatment, coupled with Chinese medicine treatments with respect to their sorted groupings. The treatment lasts for 12 weeks and 360 clinical cases were studied. Testing methods used include enzyme linked immunosorbent assay, Western Blot, FQ RT-PCR, LC-MS, and radiology. Through the relations between Neurotransmitter - endocrine hormone - immune cytokine network, blood rheology, vascular structure and endothelial function, interactions involving vasoactive substances with vascular endothelium and blood cells, it is hoped that the biological basis of cerebral infraction's deficiency in Qi and blood stasis syndrome can be deciphered. This will aid in the understanding of the whole process of causing the syndrome, deciphering the therapeutic mechanism involved during treatment, as well as determining the relationship between Qi, blood and blood vessels.

Interventions

DRUGYiqi huoxue

Buyang Huanwu demolition, which includes: Astragalus 60g, Radix Paeoniae Rubra 15g, ligusticum wallichii 12g, angelica sinensis 20g, earthworm 12g, flos carthami 12g and peach seed 12g. Oral administration, twice one day, for 12weeks.

DRUGYiqi group

Astragalus 60g.Oral administration, twice one day, for 12weeks.

DRUGHuoxue group

Radix Paeoniae Rubra 15g, ligusticum wallichii 12g, angelica sinensis 20g, earthworm 12g, flos carthami 12g and peach seed 12g. Oral administration, twice one day, for 12weeks.

DRUGplacebo

Dextrin,oral administration, twice one day, for 12weeks.

Sponsors

Xingtai People's Hospital
CollaboratorOTHER
Dongfang Hospital Beijing University of Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. In accordance to the Western medicine diagnostic criteria for atherosclerotic thrombotic cerebral infarction; 2. In accordance to the Chinese medicine diagnostic criteria for stroke, with deficiency in Qi and blood stasis syndrome; 3. In accordance to Stroke's diagnostic scale factor standards: asthenic Qi syndrome ≥ 10 points, blood stasis ≥ 10 points; 4. Within the recuperating stage of the illness (2 weeks to 6 months); 5. National Institutes of Health Stroke Scale (NIHSS) with a score of 3-22 points; 6. Ages within 35-80; 7. Signature of consent to participate in the research.

Exclusion criteria

1. Patients suffering from transient ischemic attack (TIA), subarachnoid haemorrhage and cerebral haemorrhage; 2. Patients suffering from cerebral embolism due to superficiality extremities caused by rheumatic heart disease, coronary heart disease and other heart diseases coupled with atrial fibrillation; stroke patients caused by brain tumor, head trauma, blood diseases, etc; 3. Pregnant women or women planning for pregnancy, women with positive urine pregnancy test, and lactating women; 4. Patients with severe hepatic and renal dysfunction, severe disease of the hematopoietic system, highly active ulcer and bleeding tendency, severe disease of the endocrine system, severe bone and joint disease, and arrhythmia patients with great clinical significance; 5. Patients with mental impairment, or mental disability, or severely deaf, or unconscious, or being uncooperative during inspection; 6. Patients with known allergies to the medicine used, as well as overly sensitive patients; 7. Patients that underwent clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frameDescription
National Institute of Health Stroke Scale12 weeksNIHSS

Secondary

MeasureTime frameDescription
Modified Rankin scale12 weeks0-5scales
Barthel index12 weeks0-100scales

Countries

China

Contacts

Primary ContactGuo Ronguan, PhD,MD
Dfguorongjuan@163.com+86 10 67689634
Backup ContactGuo Rongjuan, PhD,MD
Dfguorongjuan@163.com+86 10 67689634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026