One Research on Improving Cognitive Impairment Caused by Hypertension

NCT03943420 | Unknown DMC

• 1 other identifier: BE2017770
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Safety; Effectiveness; Therapy; Qianyang Yuyin Granules; Cognitive impairment; Hypertension

Outcome Measures

Primary Outcomes (2)

• Changes of brain image

  Measure and record the volume changes of diseased alba, the micro-structure changes of alba fasciculus by MRI to see if the therapy effect or not.

  24 weeks

• Measure and assess the changes of VaDAS-cog ( Vascular Dementia Assessment Scale cognitive subscale ) among time points

  Measure and record with VaDAS-cog

  12 weeks, 24 weeks, 48 weeks

Secondary Outcomes (6)

• Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points

  12 weeks, 24 weeks, 48 weeks

• Measure and assess the changes of ADL ( Activity of Daily Living ) among time points

  12 weeks, 24 weeks, 48 weeks

• Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points

  12 weeks, 24 weeks, 48 weeks

• Incidence rate of outcome event

  24 weeks

• Therapeutic effect

  24 weeks

Study Arms (3)

Experimental Group

Therapy A : Basic treatment + Qianyang Yuyin Granules

Negative Control Group

Therapy B : Basic treatment

Positive Control Group

Therapy C : Basic treatment + Donepezil

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cognitive impairment caused by hypertension.

You may qualify if:

• 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；
• ≤ 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。

You may not qualify if:

• 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。

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital of Chinese Medcine

Nanjing, Jiangsu, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample; Urine sample.

MeSH Terms

Conditions

Hypertension; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Cheng Chang, PhD

CONTACT

+8613851821996; chch1967@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: May 9, 2019
• Study Start: December 28, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 9, 2019

Record last verified: 2019-04

Locations

CN (1)