Clinical trial NCT03943420: One Research on Improving Cognitive Impairment Caused by Hypertension
Official title: One Research on Application of Key Technologies About Improving Cognitive Impairment Caused by Hypertension With the Therapy of Early Intervention With Qianyang Yuyin Granules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Safety
Effectiveness
Therapy
Qianyang Yuyin Granules
Cognitive impairment
Hypertension
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 144
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cognitive impairment caused by hypertension.

Brief summary: Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

Detailed description: Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

The investigators designed a multi-center randomized controlled clinical trial to study the security and effectiveness of this therapy.

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。

Primary outcomes:
measure: Changes of brain image
timeFrame: 24 weeks
measure: Measure and assess the changes of VaDAS-cog ( Vascular Dementia Assessment Scale cognitive subscale ) among time points
timeFrame: 12 weeks, 24 weeks, 48 weeks
Secondary outcomes:
measure: Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Measure and assess the changes of ADL ( Activity of Daily Living ) among time points
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Incidence rate of outcome event
timeFrame: 24 weeks
measure: Therapeutic effect
timeFrame: 24 weeks
measure: Metabonomics
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medcine
state: Jiangsu
Study officials:
References: