One Research on Improving Cognitive Impairment Caused by Hypertension

One Research on Application of Key Technologies About Improving Cognitive Impairment Caused by Hypertension With the Therapy of Early Intervention With Qianyang Yuyin Granules

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

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 144

Contacts and Locations

• Study Contact: Name: Cheng Chang, PhD; Phone Number: +8613851821996; Email: chch1967@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Province Hospital of Chinese Medcine
      • Contact: Cheng Chang, PhD; Phone Number: +8613851821996; Email: chch1967@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cognitive impairment caused by hypertension.

Description

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。

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Experimental Group; Therapy A : Basic treatment + Qianyang Yuyin Granules
Negative Control Group; Therapy B : Basic treatment
Positive Control Group; Therapy C : Basic treatment + Donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points	Measure and record with MMSE	12 weeks, 24 weeks, 48 weeks
Measure and assess the changes of ADL ( Activity of Daily Living ) among time points	Measure and record with ADL	12 weeks, 24 weeks, 48 weeks
Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points	Measure and record with CDR	12 weeks, 24 weeks, 48 weeks
Incidence rate of outcome event	Record the outcome event and analyse the incidence rate	24 weeks
Therapeutic effect	Measure and record patients' systolic and diastolic blood pressure and analyse related data	24 weeks
Metabonomics	Measure and record the metabonomics ( Trx & TrxR ) index	24 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Hypertension; Cognitive impairment; Therapy; Effectiveness; Qianyang Yuyin Granules
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Neurocognitive Disorders; Cognition Disorders; Hypertension; Cognitive Dysfunction
• Other Study ID Numbers: BE2017770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No