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

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01918722
• Other study ID #: JDZX2012074
• Secondary ID: JDZX2012074
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 18, 2013
• Last updated: March 10, 2016
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• ICH-1(herbal medicine with Hirudo, Tabanus)
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
• placebo
placebo herbal medicine, one dose,bid, for 10 days
• ICH-2(herbal medicine without Hirudo, Tabanus)
(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days

Locations

Country	Name	City	State
China	The hospital of Chinese Medicine of Conghua City	Conghua	Guangdong
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Guangzhou Hospital of Integrated traditional and west medicine	Guangzhou	Guangdong
China	Panyu Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Boluo County People's Hospital	Huizhou	Guangdong
China	Jiangmen Wuyi Traditional Chinese Medicine Hospital	Jiangmen	Guangdong
China	Lianjiang People's hospital	Lianjiang	Guangdong
China	Liaocheng City People's Hospital	Liaocheng	Shandong
China	Shenyang No.2 traditional Chinese medical hospital	Shenyang	Liaoning
China	Shouguang City People's Hospital	Shouguang	Shandong
China	Yangjiang Hospital of Traditional Chinese Medicine	Yangjiang	Guangdong
China	1st people's hospital of Yueyang city	Yueyang	Hunan
China	Boji-affiliated Hospital of Sun Yat-sen University	Zengcheng	Guangdong
China	Zengcheng City Hospital of traditional Chinese Medicine	Zengcheng	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma enlargement		24hrs, 10-14days	Yes
Secondary	fatality rate		3 month	No
Secondary	modified rankin scale		3 months	No
Secondary	National Institute of Health of stroke scale		10-14days, 90days	No