search
Back to results

Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction

Primary Purpose

Cerebral Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yiqi huoxue
Yiqi group
Huoxue group
placebo
Sponsored by
Dongfang Hospital Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring cerebral infarction, syndrome of qi deficiency and blood stasis, Buyanghuanwu decoction, clinical effects and mechanisms

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongfang HospitalRecruiting
  • Xingtai People's HospitalRecruiting
  • The First Affiliated Hospital of Henan Univerisity of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Yiqi huoxue group

Yiqi group

Huoxue group

placebo group

Arm Description

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.

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

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.

dextrin, Oral administration, twice one day, for 12weeks.

Outcomes

Primary Outcome Measures

National Institute of Health Stroke Scale
NIHSS

Secondary Outcome Measures

Modified Rankin scale
0-5scales
Barthel index
0-100scales

Full Information

First Posted
March 20, 2016
Last Updated
February 8, 2018
Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Xingtai People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02846207
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborators
Xingtai People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
cerebral infarction, syndrome of qi deficiency and blood stasis, Buyanghuanwu decoction, clinical effects and mechanisms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yiqi huoxue group
Arm Type
Experimental
Arm Description
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.
Arm Title
Yiqi group
Arm Type
Experimental
Arm Description
Astragalus 60g. Oral administration, twice one day, for 12weeks.
Arm Title
Huoxue group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
dextrin, Oral administration, twice one day, for 12weeks.
Intervention Type
Drug
Intervention Name(s)
Yiqi huoxue
Other Intervention Name(s)
tonifying Qi and activating blood
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Yiqi group
Other Intervention Name(s)
tonifying qi, benefiting qi
Intervention Description
Astragalus 60g.Oral administration, twice one day, for 12weeks.
Intervention Type
Drug
Intervention Name(s)
Huoxue group
Other Intervention Name(s)
activating blood
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
a soothing restorative agency
Intervention Description
Dextrin,oral administration, twice one day, for 12weeks.
Primary Outcome Measure Information:
Title
National Institute of Health Stroke Scale
Description
NIHSS
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Modified Rankin scale
Description
0-5scales
Time Frame
12 weeks
Title
Barthel index
Description
0-100scales
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In accordance to the Western medicine diagnostic criteria for atherosclerotic thrombotic cerebral infarction; In accordance to the Chinese medicine diagnostic criteria for stroke, with deficiency in Qi and blood stasis syndrome; In accordance to Stroke's diagnostic scale factor standards: asthenic Qi syndrome ≥ 10 points, blood stasis ≥ 10 points; Within the recuperating stage of the illness (2 weeks to 6 months); National Institutes of Health Stroke Scale (NIHSS) with a score of 3-22 points; Ages within 35-80; Signature of consent to participate in the research. Exclusion Criteria: Patients suffering from transient ischemic attack (TIA), subarachnoid haemorrhage and cerebral haemorrhage; 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; Pregnant women or women planning for pregnancy, women with positive urine pregnancy test, and lactating women; 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; Patients with mental impairment, or mental disability, or severely deaf, or unconscious, or being uncooperative during inspection; Patients with known allergies to the medicine used, as well as overly sensitive patients; Patients that underwent clinical trials within the past 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo Ronguan, PhD,MD
Phone
+86 10 67689634
Email
Dfguorongjuan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guo Rongjuan, PhD,MD
Phone
+86 10 67689634
Email
Dfguorongjuan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Xiangzhe, PHD,MD
Organizational Affiliation
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wang Jianhua, PHD,MD
Organizational Affiliation
Xingtai People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Rongjuan, PhD,MD
Phone
+86 10 67689634
Email
Dfrongjuanguo@163.com
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
ZIP/Postal Code
054001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jianhua, PhD,MD
Facility Name
The First Affiliated Hospital of Henan Univerisity of TCM
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Xiangzhe, PhD,MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction

We'll reach out to this number within 24 hrs