Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
NCT ID: NCT03354026
Last Updated: 2017-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
306 participants
INTERVENTIONAL
2017-11-30
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental: AICH-PXZY
Removing 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).
AICH-PXZY
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
AICH-without PXZY
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Experimental: AICH-without PXZY
Removing 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).
AICH-PXZY
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
AICH-without PXZY
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Placebo: AICH-placebo
The 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).
AICH-PXZY
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
AICH-without PXZY
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Interventions
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AICH-PXZY
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
AICH-without PXZY
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* acute cerebral hemorrhage confirmed by brain CT scan within 6 to72 hours from onset
* GCS≥6
* Sign the informed consent form
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Lianjiang people's Hospital
UNKNOWN
Shenyang Second Hospital of traditional Chinese Medicine
UNKNOWN
The Third People's Hospital of Hubei Province
OTHER
Liaocheng People's Hospital
OTHER
Zengcheng Hospital of traditional Chinese Medicine
UNKNOWN
Shouguang people's Hospital
UNKNOWN
Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Locations
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Guangdong Provincial Science and Technology Agency
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Central Contacts
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References
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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.
Other Identifiers
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JDZX2015048
Identifier Type: -
Identifier Source: org_study_id