Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03943420
Eligibility Criteria:
Inclusion Criteria:
* Aged 55 to 75 years old, male or female;
* Having a history of hypertension for more than 2 years but can maintain SBP ≤ 140 mmHg and BDP ≤ 90 mmHg with medication；
* 21 ≤ MMSE \< 26, or 14 ≤ MoCA \< 26, CDR \< 0.5. Bseides, the chief complaint must happen after having hypertension；
* Meet TCM Syndrome Differentiation Standard：according to the Guidelines for the Clinical Research of Chinese Medicine New Drugs ( published by China Medical Science Press ) ：Overabundant liver-fire type：dizziness and headache, both face and eyes are red, dry mouth and bitter taste in mouth, red tongue with yellowish coating, wire and frequent pulse. Yin deficiency and yang hyperactivity type: dizziness and headache, Tinnitus and forgetfulness, sphoria with feverish sensation in chest \& palms \& soles, palpitation and insomnia, red tongue \& thin white or less coating, wiry weak and numbered pulse；
* CTMRI hint: leukoaraiosis and no sign of Cerebral infarction；
* Patients or the guardian hold the right opinions over the research and are willing to obey researcher's orders；
* Having a certain degree of education (being able to read simple newspapers in the past)；
* Patients agree to sign informed consent。
Exclusion Criteria:
* Secondary hypertension；
* Taking certain kinds of antihypertensive drugs which may damage brain cognitive function；
* Diagnosed as depression or other mental disorders according to DSM-IV；
* Diagnosed as vascular dementia according to diagnostic criteria, CDR ≥ 0.5; alzheimer disease or dementia caused by some other reasons (including mixed dementia according to diagnostic criteria for VCI); cognitive impairment due to head injury。
* Suffering from certain kinds of diseases which may interfere the assessment of cognitive function, including those who are diagnosed as alcoholics and drugs or psychotropic medicine abusers during the last 5 years according to DSM-IV；
* Accompanied with severe neurological function disorder；
* Asthma, chronic severe primary cardiovascular disease, liver lesion, hematological lesions, lung diseases, diabetes or other severe diseases may influence the patients' survival such as cancer or AIDS；
* Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons；
* Taking the same kind of medicine during the last 30 days which may influence the trial；
* Is participating in another clinical study；
* Not up to TCM Syndrome Differentiation Standard。
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT03943420
Study Brief:
Protocol Section:
NCT03943420