Xinglou Chengqi Granules for Stroke
(EXACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a herbal treatment called Xinglou Chengqi Granules for individuals who have recently experienced an acute ischemic stroke, a condition where a blood clot blocks blood flow to the brain. Researchers aim to determine the optimal dose and assess its safety and effectiveness. Participants will be divided into two groups: one receiving a high dose and the other a low dose with a placebo. The trial suits those diagnosed with an acute ischemic stroke within the past week and experiencing related symptoms. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using other traditional Chinese medicine for treating acute ischemic stroke, you cannot participate in this trial.
Is there any evidence suggesting that Xinglou Chengqi Granules are likely to be safe for humans?
Research has shown that Xinglou Chengqi Granules have been tested in people before. These studies focused on treating acute ischemic stroke, which occurs when blood flow to the brain is blocked. Results suggest that most patients tolerated the treatment well.
The trials did not reveal any major safety issues, indicating that most people did not experience harmful side effects. At least one earlier human trial has already assessed the treatment, which is a positive sign for its safety. However, since this trial remains in an early stage, it aims to determine the best dose and closely monitor safety. More information is needed about how different doses affect different people.12345Why do researchers think this study treatment might be promising for stroke?
Xinglou Chengqi Granules are unique because they offer a novel approach to treating stroke by utilizing traditional Chinese medicine principles. Unlike standard treatments that often focus on clot removal or prevention, these granules aim to enhance recovery by clearing internal heat and promoting bowel movements, potentially improving neurological function. Researchers are excited about this treatment because it could provide a complementary option to existing therapies, possibly reducing side effects and improving patient outcomes. Additionally, the trial explores both high-dose and low-dose options, which may help tailor the treatment to individual patient needs.
What evidence suggests that Xinglou Chengqi Granules might be an effective treatment for acute ischemic stroke?
Research has shown that Xinglou Chengqi Granules may help treat stroke. Studies have found that these granules can improve brain function and reduce damage in animals with brain injuries. This trial will compare different dosages of Xinglou Chengqi Granules. Participants in the high-dose group will receive 16 g of the granules, while those in the low-dose group will receive 8 g of the granules along with 8 g of placebo. Although more research in humans is needed, the initial findings are promising for those considering this treatment for sudden strokes.12346
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 who've had an acute ischemic stroke within the last 7 days, scoring between 6 and less than 20 on the NIHSS scale. They must fit Traditional Chinese Medicine criteria for certain syndromes and be able to give consent. Excluded are those with severe pre-stroke disabilities, life expectancy under 3 months, substance abuse history, allergies to trial drugs, pregnancy/breastfeeding women, or severe organ dysfunction.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 16 g of Xinglou Chengqi granules or 8 g of Xinglou Chengqi granules with 8 g of placebo for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at days 7, 14, 30, 60, and 90
What Are the Treatments Tested in This Trial?
Interventions
- Xinglou Chengqi Granule
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dongzhimen Hospital, Beijing
Lead Sponsor