Clinical trial NCT02846207: Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction
Official title: Study of Effects and Mechanisms of Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Infarction
Keywords: cerebral infarction
syndrome of qi deficiency and blood stasis
Buyanghuanwu decoction
clinical effects and mechanisms
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xingtai People's Hospital
First posted: 2016-07-27
Enrollment: 360
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: National Institute of Health Stroke Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Modified Rankin scale
timeFrame: 12 weeks
measure: Barthel index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongfang Hospital
state: Beijing
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan Univerisity of TCM
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Liu Xiangzhe, PHD,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xingtai People's Hospital
name: Wang Jianhua, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References: