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| Sponsored by: |
Nanjing University of Traditional Chinese Medicine |
|---|---|
| Information provided by: | Nanjing University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT00569088 |
Purpose
The purpose of this study is to determine whether the Chinese herbs formula is effective in the treatment of hemorrhagic stroke and to find out Chinese pathogeny and pathogenesis in the disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Chinese herbs formula Drug: Mannitol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | "973" Project for Pathology of Traditional Chinese Medicine |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
B: Experimental
A combined treatment would be used in the arm.That means Chinese herb formula would be used with the current Modern Medicine therapy for stroke in this arm.
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Drug: Chinese herbs formula
The chinese herbs formula includes eight herbs,and they are Radix et Rhizoma Rhei Palmati(Rhubarb,10 grams),Cornu Bubali(Buffalo Horn,30 grams),Radix Paeoniae Bubra(Red Peony Root,15 grams),Cortex Moutan Radicis(Tree Peony Root-bark,10 grams),Radix Rehmanniae(Adhesive Rehmannia Root Tuber,20 grams),Pheretima Aspergillum(Earth-worm,10 grams),Radix Notoginseng(Sanchi,5 grams)and Rhizoma Acori Tarainowii(Tararinow Sweetflag Rhizome,10 grams). Boiled together. 150ml of the juice,p.o.,twice a day,for 28 days
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A: Active Comparator
just the current Modern Medicine therapy for stroke would be available in the arm.
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Drug: Mannitol
250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days
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Blood stasis and blood heat are two pathogens in the theory system of Chinese Medicine, which can cause many diseases independently. But in internal intractable diseases, such as viral hepatitis, stroke, and epidemic hemorrhagic fever, blood stasis and blood heat always accompany with each other. So the hypothesis is raised that blood stasis with heat (YURE) is a compound pathogen and key pathogenesis in internal intractable diseases. This study was aimed to verify the role that the compound pathogen played in hemorrhagic stroke and to observe the progress of the key pathogenesis. A randomized and controlled trial would be conducted in five hospitals, where 300 hospitalized patients with hemorrhagic stroke in the acute phase would receive different intervention with basic modern medicine treatment or Chinese herbs formula combined with the former. The Chinese herbs formula, which was designed under the guidance of the theory system of Chinese Medicine, was supposed to cool blood heat and dissolve blood stasis. Clinical efficacy and safety would be evaluated after the 21-days intervention.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Fang Ye, Dr. | 8625-86798189 | yeflm@yahoo.com.cn |
| China, Jiangsu | |
| Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine | Recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Fan Ye, Dr. 8625-86798189 yeflm@yahoo.com.cn | |
| Principal Investigator: Mianhua Wu, Dr. | |
| Sub-Investigator: Xueping Zhou, Dr. | |
| Sub-Investigator: Weifeng Guo, Dr. | |
| Sub-Investigator: Xizheng Gu, Dr. | |
| Principal Investigator: | Mianhua Wu, Dr. | Nanjing Uinversity of Traditional Chinese Medicine |
More Information
| Responsible Party: | Nanjing University of Traditional Chinese Medicine ( Mianhua Wu ) |
| Study ID Numbers: | 2006CB504807 |
| Study First Received: | November 28, 2007 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00569088 History of Changes |
| Health Authority: | China: Ministry of Health |
|
hemorrhagic stroke Chinese Medicine pathogenesis YURE |
|
Glycerol Cerebral Infarction Mannitol Diuretics Stroke |
Vascular Diseases Central Nervous System Diseases Cardiovascular Agents Brain Diseases Cerebrovascular Disorders |
|
Diuretics, Osmotic Stroke Nervous System Diseases Diuretics Physiological Effects of Drugs Vascular Diseases Central Nervous System Diseases Cardiovascular Agents |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Mannitol Natriuretic Agents Therapeutic Uses Cardiovascular Diseases |
