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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Infarction
• Intervention / Treatment: Drug: Yiqi huoxue; Drug: Yiqi group; Drug: Huoxue group; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guo Ronguan, PhD,MD; Phone Number: +86 10 67689634; Email: Dfguorongjuan@163.com
• Study Contact Backup: Name: Guo Rongjuan, PhD,MD; Phone Number: +86 10 67689634; Email: Dfguorongjuan@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100078
      • Recruiting
      • Dongfang Hospital
      • Contact: Guo Rongjuan, PhD,MD; Phone Number: +86 10 67689634; Email: Dfrongjuanguo@163.com
  • Hebei
    • Xingtai, Hebei, China, 054001
      • Recruiting
      • Xingtai People's Hospital
      • Contact: Wang Jianhua, PhD,MD
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Henan Univerisity of TCM
      • Contact: Liu Xiangzhe, PhD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yiqi huoxue group; Buyang Huanwu decoction , 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.	Drug: Yiqi 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.; Other Names: tonifying Qi and activating blood
Experimental: Yiqi group; Astragalus 60g. Oral administration, twice one day, for 12weeks.	Drug: Yiqi group; Astragalus 60g.Oral administration, twice one day, for 12weeks.; Other Names: tonifying qi; benefiting qi
Experimental: Huoxue 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.	Drug: Huoxue 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.; Other Names: activating blood
Placebo Comparator: placebo group; dextrin, Oral administration, twice one day, for 12weeks.	Drug: placebo; Dextrin,oral administration, twice one day, for 12weeks.; Other Names: a soothing restorative agency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institute of Health Stroke Scale	NIHSS	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin scale	0-5scales	12 weeks
Barthel index	0-100scales	12 weeks

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Collaborators: Xingtai People's Hospital
• Investigators: Principal Investigator: Liu Xiangzhe, PHD,MD, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Principal Investigator: Wang Jianhua, PHD,MD, Xingtai People's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 20, 2016
• First Submitted That Met QC Criteria: July 24, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: cerebral infarction; syndrome of qi deficiency and blood stasis; Buyanghuanwu decoction; clinical effects and mechanisms
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Cerebral Infarction
• Other Study ID Numbers: 2015CB554401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED