HypertensionNCT03943420
One Research on Improving Cognitive Impairment Caused by Hypertension
An observational study of Hypertension, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
Trial summary
Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Hypertension
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2018to Dec 2020
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cognitive impairment caused by hypertension.
Who may be able to join
- 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。
Who cannot join
- 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；
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- 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。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital of Chinese Medcine
Nanjing, Jiangsu, 210000
Cheng Chang, PhD, +8613851821996, chch1967@163.com
About this study
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
Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.
Read the 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.
- Conditions
- Hypertension
- Keywords
- Safety, Effectiveness, Therapy, Qianyang Yuyin Granules, Cognitive impairment, Hypertension
- Medical subject headings
- Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks, 24 weeks, 48 weeks
Secondary outcomes (6)
Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points
Measure and record with MMSE
Measured: 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
Measured: 12 weeks, 24 weeks, 48 weeks
Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points
Measure and record with CDR
Measured: 12 weeks, 24 weeks, 48 weeks
Incidence rate of outcome event
Record the outcome event and analyse the incidence rate
Measured: 24 weeks
Therapeutic effect
Measure and record patients' systolic and diastolic blood pressure and analyse related data
Measured: 24 weeks
Metabonomics
Measure and record the metabonomics ( Trx \& TrxR ) index
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start28 Dec 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943420
- Sponsor's protocol ID
- BE2017770
- Status last verified
- Apr 2019
- First submitted
- 29 Jan 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03943420
- Acronym / sponsor ID
- BE2017770
- Conditions
- Hypertension
- Keywords
- Safety, Effectiveness, Therapy, Qianyang Yuyin Granules, Cognitive impairment, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –Therapy A : Basic treatment + Qianyang Yuyin Granules |
| Negative Control Group | – | –Therapy B : Basic treatment |
| Positive Control Group | – | –Therapy C : Basic treatment + Donepezil |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cognitive impairment caused by hypertension.
Key inclusion criteria (8 listed)
- 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；
Key exclusion criteria (11 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of brain image
Time frame: 24 weeks
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.
Measure and assess the changes of VaDAS-cog ( Vascular Dementia Assessment Scale cognitive subscale ) among time points
Time frame: 12 weeks, 24 weeks, 48 weeks
Measure and record with VaDAS-cog
6 secondary outcomes
Measure and assess the changes of MMSE ( Mini-mental State Examination ) among time points
Time frame: 12 weeks, 24 weeks, 48 weeks
Measure and assess the changes of ADL ( Activity of Daily Living ) among time points
Time frame: 12 weeks, 24 weeks, 48 weeks
Measure and assess the changes of CDR ( Clinical Dementia Rating ) among time points
Time frame: 12 weeks, 24 weeks, 48 weeks
Incidence rate of outcome event
Time frame: 24 weeks
Therapeutic effect
Time frame: 24 weeks
Metabonomics
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Chang, PhD (+8613851821996, chch1967@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of brain image (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.