aotai Fang for prevention and treatment of hypertensive cerebral small vessel disease: randomized, double-blind, placebo-controlled, multi-center clinical trial protocol
- Conditions
- Hypertension-induced cerebral small vessel disease
- Registration Number
- ITMCTR1900002466
- Lead Sponsor
- Hu'nan University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Agec between 40-80 years old;
2. Compliance with patients with essential hypertension;
3. According to the General Consensus of Diagnosis and Treatment of Cerebral Small Vascular Diseases, MRI confirmed cerebral small vessel disease, but yes or no clinical manifestations of brain damage;
4. TCM syndrome differentiation standard: refer to the Interpretation of TCM Clinical Diagnosis and Treatment Guidelines. Syndrome based on wind-phlegm stagnant blood syndrome;
5. Voluntary participation in the trial and signing of informed consent.
1. Serious life-threatening diseases such as acute myocardial infarction, stroke, cardiac insufficiency, grade IV, etc;
2. Imaging and other diseases to exclude hypertensive cerebral small vessel disease;
3. Hypertension can not be controlled by using antihypertensive drugs;
4. Patients with cerebral macrovascular disease;
5. Allergic or research drug known to be allergic to ingredients;
6. Suspected or indeed have a history of alcohol or drug abuse, or according to the judgment of the investigator, other lesions or conditions that reduce the likelihood of enrollment or complicate the enrollment, such as frequent changes in the working environment and unstable living environment, may cause loss of follow-up Case;
7. Suffering from any serious psychological abnormalities and mental disorders, unable to comply with clinical research procedures and norms, and other researchers believe that it is not suitable for inclusion;
8. Preparing a pregnant or lactating woman within one or six months of pregnancy;
9. Patients who are participating in other clinical trials or have participated in other clinical trials in the past month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI (The number of craniocerebral, the number of microbleeds, the Fazekas score, and the grading criteria for the severity of d VRS in different brain regions);
- Secondary Outcome Measures
Name Time Method blood pressure;TCM syndrome points;