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Intracerebral HemorrhagePhase 4NCT01918722

Clinical Re-evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

A Phase 4 study testing ICH-1(herbal medicine with Hirudo, Tabanus) and ICH-2(herbal medicine without Hirudo, Tabanus) in people with Intracerebral Hemorrhage, run by Guangzhou University of Traditional Chinese Medicine at 15 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
ICH-1(herbal medicine with Hirudo, Tabanus) and ICH-2(herbal medicine without Hirudo, Tabanus)
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
15 sitesChina
Study dates
Oct 2013to Dec 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • no younger than 18 yrs
  • acute cerebral hemorrhage confirmed by brain CT scan
  • within 6 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

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Guangzhou Hospital of Integrated traditional and west medicine

    Guangzhou, Guangdong, 510800

  • Panyu Hospital of Chinese Medicine

    Guangzhou, Guangdong, 511400

  • Boluo County People's Hospital

    Huizhou, Guangdong, 514610

  • Jiangmen Wuyi Traditional Chinese Medicine Hospital

    Jiangmen, Guangdong, 529000

  • The hospital of Chinese Medicine of Conghua City

    Jiekou, Guangdong, 5109000

  • Lianjiang People's hospital

    Lianjiang, Guangdong, 524400

  • Liaocheng City People's Hospital

    Liaocheng, Shandong, 252000

  • Zengcheng City Hospital of traditional Chinese Medicine

    Licheng, Guangdong, 510000

  • Boji-affiliated Hospital of Sun Yat-sen University

    Licheng, Guangdong, 511300

  • Shenyang No.2 traditional Chinese medical hospital

    Shenyang, Liaoning, 110000

  • Shouguang City People's Hospital

    Shouguang, Shandong, 262700

  • Yangjiang Hospital of Traditional Chinese Medicine

    Yangjiang, Guangdong, 529500

  • 1st people's hospital of Yueyang city

    Yueyang, Hunan, 414000

Other trials in China

About this study

Official title: Clinical Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety

In order to investigate the time window of acute intracerebral hemorrhage(AICH) by "Blood Activating and Stasis Dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.

Read the detailed description

objective: to investigate the safety and effect of acute cerebral hemorrhage treated with "Blood Activating and Stasis Dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not.

Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Being tested
ICH-1(herbal medicine with Hirudo, Tabanus), placebo, ICH-2(herbal medicine without Hirudo, Tabanus)
Keywords
Activating blood stagnation and expelling blood stasis, Hematoma enlargement, herbal medicine, traditional chinese medicine, random clinical trial
Medical subject headings
Cerebral Hemorrhage

What participants receive

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

  • ICH-1(herbal medicine with Hirudo, Tabanus)Drug

    Also called PXZY

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

  • placeboDrug

    Also called pxzyp

    placebo herbal medicine, one dose,bid, for 10 days

  • ICH-2(herbal medicine without Hirudo, Tabanus)Drug

    Also called NPXZY

    (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days

Study groups in NCT01918722
Study groupRoleWhat they receive
ICH-1Experimentalherbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function
Receives: Drug: ICH-1(herbal medicine with Hirudo, Tabanus)
ICH-2Active comparatorherbal medicine without Hirudo, Tabanus,Only 6 herbals
Receives: Drug: ICH-2(herbal medicine without Hirudo, Tabanus)
placebo herbal medicinePlacebo comparatorPlacebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days
Receives: Drug: placebo

What is being measured

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

  1. Hematoma enlargement

    Measured: 24hrs, 10-14days

Secondary outcomes (3)

  1. fatality rate

    Measured: 3 month

  2. modified rankin scale

    Measured: 3 months

  3. National Institute of Health of stroke scale

    Measured: 10-14days, 90days

Timeline

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

  1. First posted8 Aug 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJun 2016 (estimated)
  4. Study completionDec 2016 (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
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01918722
Sponsor's protocol ID
JDZX2012074
Other IDs
JDZX2012074
Status last verified
Mar 2016
First submitted
18 Apr 2013
Last updated
11 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The study has recruited 278 subjects by so far

Publications

  • Zeng L, Tang G, Wang J, Zhong J, Xia Z, Li J, Chen G, Zhang Y, Luo S, Huang G, Zhao Q, Wan Y, Chen C, Zhu K, Qiao H, Wang J, Huang T, Liu X, Zhang Q, Lin R, Li H, Gong B, Chen X, Zhou Y, Wen Z, Guo J. Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial. BMJ Open. 2019 May 9;9(5):e024932. doi: 10.1136/bmjopen-2018-024932.

    PubMed 31076468

  • Zeng L, Guo J, Wang J, Zhang Q, Li H, Lin R. Clinical re-evaluation of removing blood stasis therapy in treating acute intracerebral hemorrhage safety and efficacy: a protocol for a randomized, controlled, multicenter study (CRRICH Trial). Springerplus. 2016 Sep 1;5(1):1466. doi: 10.1186/s40064-016-3136-y. eCollection 2016.

    PubMed 27652041

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ICH-1(herbal medicine with Hirudo, Tabanus) and ICH-2(herbal medicine without Hirudo, Tabanus) in people with Intracerebral Hemorrhage, run by Guangzhou University of Traditional Chinese Medicine at 15 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 5 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematoma enlargement (time frame: 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 NCT01918722, which also lists 2 linked publications.

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 11 Mar 2016.

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