AzTrials
AzTrials

Intracerebral Hemorrhage, HypertensivePhase 4CERBSTTSCHNCT03354026

Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

A Phase 4 study testing AICH-PXZY and AICH-without PXZY in people with Intracerebral Hemorrhage, Hypertensive and Traditional Chinese Medicine, run by Guangzhou University of Traditional Chinese Medicine at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this research is to use the "Removing Blood Stasis Decotion" of traditional Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated pneumonia to explore the impact of "Removing Blood Stasis Therapy" on intestinal microbial flora either within the time window from 6 to 72… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
AICH-PXZY and AICH-without PXZY
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
306 participants
Where
2 sitesChina
Study dates
Nov 2017to Dec 2022
Phase
Phase 4
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Greater than or equal to 18 years old while younger than 80 years old
  • acute cerebral hemorrhage confirmed by brain CT scan within 6 to72 hours from onset
  • GCS≥6
  • Sign the informed consent form

Who cannot join

  • Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;
  • patients with Severe heart, liver and renal insufficiency.
  • Intolerance to traditional Chinese medicine (TCM), allergic constitution.
  • patients with severe cerebral hernia in the early onset
  • Compliance is poor.

Trial locations and contacts

2 sites in 1 country.

Jianwen J Guo, Doctor contact

+86 13724899379

jianwen_guo@qq.com

Qixin Q Zhang, Master contact

+86 15626450556

446763061@qq.com

China2 sites

  • Guangdong Provincial Science and Technology Agency

    Guangzhou, Guangdong, 510033

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

The purpose of this research is to use the "Removing Blood Stasis Decotion" of traditional Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated pneumonia to explore the impact of "Removing Blood Stasis Therapy" on intestinal microbial flora either within the time window from 6 to 72 hours onset.

Read the detailed description

objective: to investigate the impact and immunologic mechanism of using the "Removing Blood Stasis Decotion" treatment in SAP after Acute Cerebral Hemorrhage with the concept of Intestinal Micro Ecological Regulation.

Methods: from 2017.01 to 2022.12, 240 cases of AICH, 306 cases of hypertension will be included in 7 research centers. The AICH patients are randomly into 3 groups within 6 to 72hrs from onset, thus there are 3 groups and the treatment will last for 10 days: group A，Removing Blood Stasis herbal medicine(8 herbals); Group B, herbal medicine without Poxuezhuyu activating herbal(6 herbals); Group C, placebo medicine of Chinese medicine.All the patients will be treated according AHA guideline of AICH and will be set to the brain CT and chest X-ray at the onset, 24h later and 10-14days after treatment. The venous blood，feces Specimen and the sputum will be collected in the time point of 6 to 72hrs within onset , 24h later, and 10-14days after treatment.So the rate of enlargement of brain hematoma and the development of SAP in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Being tested
AICH-PXZY, AICH-without PXZY, AICH-placebo
Keywords
Blood-breaking Decotion
Medical subject headings
Intracranial Hemorrhage, Hypertensive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AICH-PXZYDrug

    Also called herbal medicine with Hirudo, Tabanus

    8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days

  • AICH-without PXZYDrug

    Also called herbal medicine without Hirudo, Tabanus

    AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days

  • AICH-placeboDrug

    Also called Placebo

    The placebo is made up of Starch, bitter taste and cyclodextrin

Study groups in NCT03354026
Study groupRoleWhat they receive
Experimental: AICH-PXZYExperimentalRemoving Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Receives: Drug: AICH-PXZY; Drug: AICH-without PXZY; Drug: AICH-placebo
Experimental: AICH-without PXZYExperimentalRemoving Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Receives: Drug: AICH-PXZY; Drug: AICH-without PXZY; Drug: AICH-placebo
Placebo: AICH-placeboPlacebo comparatorThe placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
Receives: Drug: AICH-PXZY; Drug: AICH-without PXZY; Drug: AICH-placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematoma enlargement

    The hematoma volume enlarged 33% or increased 12.5ml defined as hematoma enlargement which are compared with the two CT scans(6-72h within onset and 24h after onset,or 6-72h within onset and 10-14days)

    Measured: 6-72h within onset, 24hrs, 10-14days

Secondary outcomes (6)

  1. GCS scoring scale

    The Glasgow score was used to assess the coma index.

    Measured: 6-72hours within onset, 24hours later, 3 months

  2. National Institute of Health of stroke scale

    The NIHSS is for evaluation of neurological deficits.

    Measured: 6-72hours within onset, 24hours later, 3 months

  3. BI index

    BI index <90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds.

    Measured: 3 months

  4. Social function activity questionnaire(FAQ)

    FAQ is mainly to know the quality of life and living habits of the patients and their families.

    Measured: 3 months

  5. fatality rate

    Any cause of death within the entire treatment 10ds and follow-up 90ds.

    Measured: 3 months

  6. modified rankin scale

    Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe. The percentage of mRS 0-1 points in the three groups will be statistically followed up by 90ds.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study startNov 2017 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
306 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354026
Sponsor's protocol ID
JDZX2015048
Acronym
CERBSTTSCH
Status last verified
Nov 2017
First submitted
10 Nov 2017
Last updated
27 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will keep the IPD in secret and share that only when the agreement are shown by the Ethics committee and the project committee，including the examination results, genotype, etc.

Publications

  • Zhang Q, Zeng L, Chen X, Zhou Y, Gong B, Li H, Guo J. Clinical Evaluation of Herbal Medicine (ICH-012) in Treating Acute Cerebral Haemorrhage: Safety and Efficacy from 6- to 72-Hour Time Window (CRRICHTrial-II). Evid Based Complement Alternat Med. 2018 Aug 26;2018:3120179. doi: 10.1155/2018/3120179. eCollection 2018.

    PubMed 30224926

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AICH-PXZY and AICH-without PXZY in people with Intracerebral Hemorrhage, Hypertensive and Traditional Chinese Medicine, run by Guangzhou University of Traditional Chinese Medicine at 2 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 4 inclusion and 5 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jianwen J Guo, Doctor (+86 13724899379, jianwen_guo@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematoma enlargement (time frame: 6-72h within onset, 24hrs, 10-14days). 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 NCT03354026, 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 27 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in