Clinical trial NCT03354026: Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
Official title: Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intracerebral Hemorrhage, Hypertensive
Traditional Chinese Medicine
Keywords: Blood-breaking Decotion
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Lianjiang people's Hospital
name: Shenyang Second Hospital of traditional Chinese Medicine
name: The Third People's Hospital of Hubei Province
name: Liaocheng People's Hospital
name: Zengcheng Hospital of traditional Chinese Medicine
name: Shouguang people's Hospital
First posted: 2017-11-27
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 hours onset.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hematoma enlargement
timeFrame: 6-72h within onset, 24hrs, 10-14days
Secondary outcomes:
measure: GCS scoring scale
timeFrame: 6-72hours within onset, 24hours later, 3 months
measure: National Institute of Health of stroke scale
timeFrame: 6-72hours within onset, 24hours later, 3 months
measure: BI index
timeFrame: 3 months
measure: Social function activity questionnaire(FAQ)
timeFrame: 3 months
measure: fatality rate
timeFrame: 3 months
measure: modified rankin scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Science and Technology Agency
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
References:
citation: 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.