StrokePhase 2NCT00569088
Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
A Phase 2 study testing Chinese herbs formula and Mannitol in people with Stroke, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Chinese herbs formula and Mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of hemorrhagic stroke
- hospitalized in 48 hours after hemorrhagic stroke happens
Who cannot join
- Subarachnoid Hemorrhage
- intracranial hemorrhage caused by tumor, trauma or blood diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine
Nanjing, Jiangsu
Fan Ye, Dr., 8625-86798189, yeflm@yahoo.com.cn
Mianhua Wu, Dr.
About this study
Official title: "973" Project for Pathology of Traditional Chinese Medicine
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Chinese herbs formula, Mannitol
- Keywords
- hemorrhagic stroke, Chinese Medicine, pathogenesis, YURE
- Medical subject headings
- Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbs formulaDrug
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
MannitolDrug
250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chinese herbs formula |
| A | Active comparator | just the current Modern Medicine therapy for stroke would be available in the arm. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese symptoms
Measured: 21 days
Secondary outcomes (1)
blood loss determined by brain CT
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Mianhua Wu, Dr., Principal investigator, Nanjing Uinversity of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569088
- Sponsor's protocol ID
- 2006CB504807
- Status last verified
- Jul 2009
- First submitted
- 28 Nov 2007
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "973" Project for Pathology of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT00569088
- Acronym / sponsor ID
- 2006CB504807
- Conditions
- Stroke
- Keywords
- hemorrhagic stroke, Chinese Medicine, pathogenesis, YURE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Chinese herbs formulaA 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. |
| A | Active comparator | Drug: Mannitoljust the current Modern Medicine therapy for stroke would be available in the arm. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of hemorrhagic stroke
- hospitalized in 48 hours after hemorrhagic stroke happens
Key exclusion criteria (2 listed)
- Subarachnoid Hemorrhage
- intracranial hemorrhage caused by tumor, trauma or blood diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbs formulaThe 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 | Drug | B |
| Mannitol250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days | Drug | A |
Primary outcome
Chinese symptoms
Time frame: 21 days
1 secondary outcome
blood loss determined by brain CT
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mianhua Wu, Dr. principal investigator
Nanjing Uinversity of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese herbs formula and Mannitol in people with Stroke, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Ye, Dr. (8625-86798189, yeflm@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese symptoms (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009.