Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
This study is currently recruiting participants.
Verified February 2013 by Dongfang Hospital
Sponsor:
Yunling Zhang
Collaborators:
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yunling Zhang, Dongfang Hospital
ClinicalTrials.gov Identifier:
NCT01636154
First received: June 29, 2012
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.
| Condition | Intervention |
|---|---|
|
Ischemic Stroke |
Drug: Ixeris of sonchifolia Hance Drug: Panax notoginseng saponins Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation |
Further study details as provided by Dongfang Hospital:
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: The basic treatment
Comply to the Chinese guidelines of acute ischemic stroke in 2010
|
|
|
Clearing heat
Treat with KDZ injection on the basis of the basic treatment
|
Drug: Ixeris of sonchifolia Hance
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Other Name: KDZ injection
|
|
Promoting blood circulation
Treat with Xueshuantong injection on the basis of the basic treatment
|
Drug: Panax notoginseng saponins
Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Other Name: Xueshuantong injection
|
|
Experimental: Clearing heat & Promoting blood circulation
Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment
|
Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
KDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip.qd of each 14-day cycle.Number of cycles:one.
|
Detailed Description:
The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with acute ischemic stroke
- Patients with fire-heat syndrome
- Stoke onset within 48 hours
- NIHSS scores range from 5 points to 25 points
- Age from forty to seventy-five,gender not limited
- Informed and signed the consent
Exclusion Criteria:
- Cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained
- Patients suitable for thrombolytic therapy(rt-PA, urokinase)
- Patients have received thrombolytic therapy
- Patients with serious diseases of heart,lungs,liver,kidneys
- Patients with bleeding or bleeding tendency recently
- Pregnant or lactating women
- Pre-existing neurological or psychiatric diseases that could confound the study results
- Patients be allergic to alcohol,Ixeris of sonchifolia Hance components (KDZ injection) or Panax notoginseng saponins components (Xueshuantong injection)
- Patients have participated in other clinical trials within 3 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636154
Contacts
| Contact: Yunling Zhang, PhD,MD | 86 10 67689634 |
Locations
| China, Beijing | |
| Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine | Active, not recruiting |
| Beijing, Beijing, China, 100078 | |
| Department of Neurology,Huairou Hospital of Traditional Chinese Medicine | Active, not recruiting |
| Beijing, Beijing, China, 101400 | |
| China, Shandong | |
| Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Recruiting |
| Jinan, Shandong, China, 250011 | |
| Contact: Xianghua Qi qixianghua2005@163.com | |
Sponsors and Collaborators
Yunling Zhang
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Investigators
| Study Chair: | Yunling Zhang, PhD,MD | Dongfang Hospital,Beijing University of Chinese Medicine |
More Information
No publications provided
| Responsible Party: | Yunling Zhang, President of of Dongfang Hospital, Dongfang Hospital |
| ClinicalTrials.gov Identifier: | NCT01636154 History of Changes |
| Other Study ID Numbers: | BUCMDFH9634 |
| Study First Received: | June 29, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | China: Ministry of Science and Technology |
Keywords provided by Dongfang Hospital:
|
fire-heat syndrome blood stasis syndrome method of clearing heat method of promoting blood circulation medicinal fractions-based herbal combinations |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013