NCT02846207

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

March 20, 2016

Last Update Submit

February 8, 2018

Conditions

Cerebral Infarction

Keywords

cerebral infarctionsyndrome of qi deficiency and blood stasisBuyanghuanwu decoctionclinical effects and mechanisms

Outcome Measures

Primary Outcomes (1)

  • National Institute of Health Stroke Scale

    NIHSS

    12 weeks

Secondary Outcomes (2)

  • Modified Rankin scale

    12 weeks

  • Barthel index

    12 weeks

Study Arms (4)

Yiqi huoxue group

EXPERIMENTAL

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

Yiqi group

EXPERIMENTAL

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

Drug: Yiqi group

Huoxue group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Yiqi huoxueDRUG

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.

Also known as: tonifying Qi and activating blood
Yiqi huoxue group
Yiqi groupDRUG

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

Also known as: tonifying qi, benefiting qi
Yiqi group
Huoxue groupDRUG

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.

Also known as: activating blood
Huoxue group
placeboDRUG

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

Also known as: a soothing restorative agency
placebo group

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dongfang Hospital

Beijing, Beijing Municipality, 100078, China

RECRUITING

Xingtai People's Hospital

Xingtai, Hebei, 054001, China

RECRUITING

The First Affiliated Hospital of Henan Univerisity of TCM

Zhengzhou, Henan, 450000, China

RECRUITING

Related Publications (1)

  • Li Y, Wang D, Guo R, Ma B, Miao L, Sun M, He L, Lin L, Pan Y, Ren J, Liu J. Neuroprotective effect of Astragali Radix on cerebral infarction based on proteomics. Front Pharmacol. 2023 Jun 9;14:1162134. doi: 10.3389/fphar.2023.1162134. eCollection 2023.

    PMID: 37361203DERIVED

MeSH Terms

Conditions

Cerebral Infarction

Interventions

yiki-huoxue

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Ronguan, PhD,MD

CONTACT

+86 10 67689634Dfguorongjuan@163.com

Guo Rongjuan, PhD,MD

CONTACT

+86 10 67689634Dfguorongjuan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2016

First Posted

July 27, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

CN(3)