NCT07163702Not yet recruitingPhase 2
Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke
Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke (EXACT): a Multi-center, Randomized, Double-blinded, Dose-exploration Ⅱa Trial
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Diseases
- Stroke
- NCT number
- NCT07163702
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Oct 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received or planned thrombolysis or endovascular therapy after onset.
Other illness
- Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
- Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
- With cancers or uncontrolled diabetes.
- Patients who have used other traditional Chinese medicine for treating acute ischemic stroke since stroke onset.
- Patients with severe mental disorders, dementia, or other comorbid diseases that may affect neurological function examination.
- With a history of alcohol or drug abuse or drug dependence.
- Those known to be allergic to the investigated drug or its components.
Lab values
- Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase \> 2.5 times the upper limit of normal value, serum creatinine \> 1.5 times the upper limit of normal value)
Other
- NIHSS Ⅰa ≥2.
- The expected survival time is less than 3 months.
- Pregnancy, potential pregnancy, or breastfeeding.
- Currently participating in other clinical trials during the past 3 months.
- Those who are judged by researchers to have poor compliance or are not suitable for participating in this study for any other reason.
Who the study is looking for
- Inpatients diagnosed with acute ischemic stroke.
- Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome.
- Acute ischemic stroke within 7 days after onset.
- 6 ≤ NIHSS \<20.
- Aged 18-70 years, male or female.
- The patient or representative has signed informed consent.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine Coordinator of this site? Confirm its status | Richmond | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.