NCT03354026

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage, Hypertensive
• Traditional Chinese Medicine

Interventions

Type	Name	Description
DRUG	AICH-PXZY	8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
DRUG	AICH-without PXZY	AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
DRUG	AICH-placebo	The placebo is made up of Starch, bitter taste and cyclodextrin

Timeline

• Start date: 2017-11-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2017-11-27
• Last updated: 2017-11-27

Locations

2 sites across 1 country: China