Cerebral InfarctionNCT02846207
Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction
A study testing Yiqi huoxue, Yiqi group and Huoxue group in people with Cerebral Infarction, run by Dongfang Hospital Beijing University of Chinese Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Yiqi huoxue, Yiqi group and Huoxue group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Dongfang Hospital
Beijing, Beijing Municipality, 100078
Guo Rongjuan, PhD,MD, +86 10 67689634, Dfrongjuanguo@163.com
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054001
Wang Jianhua, PhD,MD
- Recruiting
The First Affiliated Hospital of Henan Univerisity of TCM
Zhengzhou, Henan, 450000
Liu Xiangzhe, PhD,MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Infarction
- Being tested
- Yiqi huoxue, Yiqi group, Huoxue group, placebo
- Keywords
- cerebral infarction, syndrome of qi deficiency and blood stasis, Buyanghuanwu decoction, clinical effects and mechanisms
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yiqi huoxueDrug
Also called tonifying Qi and activating blood
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.
Yiqi groupDrug
Also called tonifying qi, benefiting qi
Astragalus 60g.Oral administration, twice one day, for 12weeks.
Huoxue groupDrug
Also called activating blood
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.
placeboDrug
Also called a soothing restorative agency
Dextrin,oral administration, twice one day, for 12weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Yiqi huoxue |
| Yiqi group | Experimental | Astragalus 60g. Oral administration, twice one day, for 12weeks. Receives: 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. Receives: Drug: Huoxue group |
| placebo group | Placebo comparator | dextrin, Oral administration, twice one day, for 12weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institute of Health Stroke Scale
NIHSS
Measured: 12 weeks
Secondary outcomes (2)
Modified Rankin scale
0-5scales
Measured: 12 weeks
Barthel index
0-100scales
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xingtai People's Hospital
- Responsible party
- Sponsor
- Investigators
- Liu Xiangzhe, PHD,MD, Principal investigator, The First Affiliated Hospital of Henan University of Traditional Chinese MedicineWang Jianhua, PHD,MD, Principal investigator, Xingtai People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846207
- Sponsor's protocol ID
- 2015CB554401
- Status last verified
- Feb 2018
- First submitted
- 20 Mar 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37361203
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects and Mechanisms of Yiqi Huoxue Demolition and Recipes on Recovery Stage of Cerebral Infarction
- ClinicalTrials.gov ID
- NCT02846207
- Acronym / sponsor ID
- 2015CB554401
- Conditions
- Cerebral Infarction
- Keywords
- cerebral infarction, syndrome of qi deficiency and blood stasis, Buyanghuanwu decoction, clinical effects and mechanisms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Xingtai People's Hospital
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yiqi huoxue group | Experimental | Drug: Yiqi huoxueBuyang 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. |
| Yiqi group | Experimental | Drug: Yiqi groupAstragalus 60g. Oral administration, twice one day, for 12weeks. |
| Huoxue group | Experimental | Drug: Huoxue groupRadix 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. |
| placebo group | Placebo comparator | Drug: placebodextrin, Oral administration, twice one day, for 12weeks. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yiqi huoxueAlso: tonifying Qi and activating bloodBuyang 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. | Drug | Yiqi huoxue group |
| Yiqi groupAlso: tonifying qi, benefiting qiAstragalus 60g.Oral administration, twice one day, for 12weeks. | Drug | Yiqi group |
| Huoxue groupAlso: activating bloodRadix 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 |
| placeboAlso: a soothing restorative agencyDextrin,oral administration, twice one day, for 12weeks. | Drug | placebo group |
Primary outcome
National Institute of Health Stroke Scale
Time frame: 12 weeks
NIHSS
2 secondary outcomes
Modified Rankin scale
Time frame: 12 weeks
Barthel index
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 37361203Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Xiangzhe, PHD,MD principal investigator
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Wang Jianhua, PHD,MD principal investigator
Xingtai People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yiqi huoxue, Yiqi group and Huoxue group in people with Cerebral Infarction, run by Dongfang Hospital Beijing University of Chinese Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo Ronguan, PhD,MD (+86 10 67689634, Dfguorongjuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Health Stroke Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.