Back to resultsEfficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Orthostatic Hypotension
Primary Purpose
Orthostatic Hypotension
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Routine treatment
AM
Sponsored by
About this trial
This is an interventional treatment trial for Orthostatic Hypotension
Eligibility Criteria
Inclusion Criteria: The inclusion criteria will be as follows: Patients aged over 30; Patients with orthostatic hypotension; Patients who presence of subjective memory complaint Patients who have objective evidence of cognitive impairment assessed using neurocognitive batteries Patients who is not depressed; Patients who have complete autonomy in daily living Participants who score below normal on one or both of the tests (Montreal Cognitive Assessment: score of ≥18 to ≤26 or Mini-Mental State Examination score of ≥24 to ≤27) Exclusion Criteria: The exclusion criteria will be as follows: Patients with secondary orthostatic hypotension; Patients with dementia diagnosed according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders; Patients allergic or contraindicated to Astragalus; Patients who have been treated or have a history of stroke or transient ischemic attack, claustrophobia, bipolar disorder, schizophrenia, seizures, drug or alcohol abuse, malignancies, kidney failure and dialysis treatment, liver disease (hepatitis) and kidney disease; Patients who refuse or have contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG) (pacemakers, coronary and peripheral artery stents, metal implants, claustrophobia, severe visual and/or hearing impairment); Patients using a cholinesterase inhibitor, psychoactive drugs, medications that affect the cardiovascular system, or any medication known to interact with Astragalus; Patients who are pregnant or lactating; Patients who have participated in other clinical studies within the past 3 months.
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
add-on AM
Routine treatment
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy outcome measure will be the absolute change in the Montreal Cognitive Assessment(MoCA) score between baseline and week 24.
The MOCA scale scores range from 0 to 30, with higher scores indicating better.
Secondary Outcome Measures
The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 24.
The ROCF scale scores range from 0 to 36, with higher scores indicating better.
The absolute scores change in the ROCF-copy score between baseline and week 24.
The ROCF copy scale scores range from 0 to 36, with higher scores indicating better.
The absolute scores change in the Clock-Drawing Test score between baseline and week 24.
The Clock-Drawing Test scale scores range from 0 to 5, with higher scores indicating better.
The absolute scores change in the Trail Making Test-A score between baseline and week 24.
The Trail Making Test-A scores range from 0 to 25, with higher scores indicating better.
The absolute scores change in the Digit Span Forward score between baseline and week 24.
TheDigit Span Forward score scores range from 0 to 10, with higher scores indicating better.
The absolute scores change in the Trail Making Test-B score between baseline and week 24.
The Trail Making Test-B scores range from 0 to 25, with higher scores indicating better.
The absolute scores change in the Digit Span Backward score between baseline and week 24.
TheDigit Span Forward score scores range from 0 to 9, with higher scores indicating better.
The absolute scores change in the Verbal Fluency Test score between baseline and week 24.
The Verbal Fluency Test score scores range from 0 to 14, with higher scores indicating better.
The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 24.
The Hamilton Anxiety Scale score scores range from 0 to 56, with higher scores indicating worse.
The absolute scores change in the Hamilton Depression Scale score between baseline and week 24.
The Hamilton Anxiety Scale score scores range from 0 to 96, with higher scores indicating worse.
The absolute change in the blood pressure between baseline and week 24.
To observe the changes of orthostatic blood pressure in patients
The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 24.
Amyloid is one of the main biomarkers of dementia
The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 24.
Amyloid is one of the main biomarkers of dementia
The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 24.
Glial fibrillary acidic protein is one of the main biomarkers of dementia
The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 24.
Neurofilament light chain is one of the main biomarkers of dementia
The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 24.
Neurofilament light chain is one of the main biomarkers of dementia
The absolute change in the P300 between baseline and week 24.
P300 is the main indicator of EEG, and its normal value range is between 320 and 420.
The absolute change in the VP300 between baseline and week 24.
VP300 is the main indicator of EEG, and its normal value range is between 320 and 420.
The absolute change in the MMN between baseline and week 24.
MMN is the main indicator of EEG, and its normal value range is between 100 and 210.
The absolute change in the neurite density index between baseline and week 24.
Neurite density index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
The absolute change in the orientation dispersion index between baseline and week 24.
Orientation dispersion index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
The absolute change in the isotropic volume fraction between baseline and week 24.
Isotropic volume fraction is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
The absolute change in theheart rate variability between baseline and week 24.
The KARDi2/4-B autonomic nervous function mapping ECG system (Nanjing Left and Right Brain Biomedical Company, NeuroMed, China) will record and analyze millivolt-level signals of ECG oscillations, complete the frequency domain and time domain index detection of heart rate variability in 3 min, and generate an autonomic nervous function status step map.
Full Information
NCT ID
NCT05647473
First Posted
December 4, 2022
Last Updated
October 11, 2023
Sponsor
Fujian Medical University Union Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05647473
Brief Title
Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Orthostatic Hypotension
Official Title
Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Orthostatic Hypotension: an add-on, Assessor-blind, Pragmatic Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Introduction: Orthostatic hypotension (OH) increases the risk of cognitive impairment in adults. Recent big data studies have demonstrated that add-on Astragalus can improve OH state. In vitro studies have revealed that Astragalus possesses anti-inflammatory, antioxidative, and neuroprotective effects. However, the clinical effects of add-on Astragalus in improving cognition in these patients remain unclear. Therefore, this pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus in improving cognition in patients with OH, elucidate the underlying mechanisms, identify related response predictors, and explore effective drug components.
Methods and analysis: This is an add-on, assessor-blinded, parallel, pragmatic, randomized controlled trial. At least 88 adults with OH aged >30 years will be recruited. Participants will be randomized in a 1:1 ratio to receive 24 weeks of routine care or add-on Astragalus. The primary efficacy outcome will be measured by the Montreal Cognitive Assessment-Chinese version score. Secondary efficacy outcome assessment will include neuropsychological tests, blood pressure, plasma biomarkers, multimodal electroencephalograms, and neuroimaging. Safety outcome measures will include physical examinations, vital signs, electrocardiography, laboratory tests (such as hematologic and blood chemical tests), and adverse event records. Recruitment began on June 20, 2023.
Ethics and dissemination: The Ethics Committee of Fujian Medical University Union Hospital has approved this study (2021KJCX040).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
add-on AM
Arm Type
Experimental
Arm Title
Routine treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Routine treatment
Intervention Description
Participants will be educated on ways to avoid induced hypotensive states, such as avoiding prolonged standing, standing after exercise, being nervous, eating several carbohydrate-rich foods, drinking alcohol, and being in a warm environment (such as a sauna). Participants will be encouraged in a comfortable home environment, such as a sit-down bath. If there are no contraindications, they are advised to increase their salt intake to approximately 10 grams per day and adjust their fluid intake to 2-3 liters per day. They will also be encouraged to perform lower-body strength training and moderate, non-strenuous activities. Seriously ill patients will be proposed to raise the head of their bed during sleep, wear tight clothing, eat small meals, and reduce alcohol intake.
Intervention Type
Drug
Intervention Name(s)
AM
Intervention Description
Patients will receive astragalus daily 15g for 24 weeks
Primary Outcome Measure Information:
Title
The primary efficacy outcome measure will be the absolute change in the Montreal Cognitive Assessment(MoCA) score between baseline and week 24.
Description
The MOCA scale scores range from 0 to 30, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Secondary Outcome Measure Information:
Title
The absolute scores change in the Rey-Osterrieth Complex Figure Test [ROCF] recall score between baseline and week 24.
Description
The ROCF scale scores range from 0 to 36, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the ROCF-copy score between baseline and week 24.
Description
The ROCF copy scale scores range from 0 to 36, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Clock-Drawing Test score between baseline and week 24.
Description
The Clock-Drawing Test scale scores range from 0 to 5, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Trail Making Test-A score between baseline and week 24.
Description
The Trail Making Test-A scores range from 0 to 25, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Digit Span Forward score between baseline and week 24.
Description
TheDigit Span Forward score scores range from 0 to 10, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Trail Making Test-B score between baseline and week 24.
Description
The Trail Making Test-B scores range from 0 to 25, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Digit Span Backward score between baseline and week 24.
Description
TheDigit Span Forward score scores range from 0 to 9, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Verbal Fluency Test score between baseline and week 24.
Description
The Verbal Fluency Test score scores range from 0 to 14, with higher scores indicating better.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Hamilton Anxiety Scale score between baseline and week 24.
Description
The Hamilton Anxiety Scale score scores range from 0 to 56, with higher scores indicating worse.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute scores change in the Hamilton Depression Scale score between baseline and week 24.
Description
The Hamilton Anxiety Scale score scores range from 0 to 96, with higher scores indicating worse.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the blood pressure between baseline and week 24.
Description
To observe the changes of orthostatic blood pressure in patients
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the level of plasma β-amyloid40 (ng/ml) between baseline and week 24.
Description
Amyloid is one of the main biomarkers of dementia
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the level of plasma β-amyloid42 (ng/ml) between baseline and week 24.
Description
Amyloid is one of the main biomarkers of dementia
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the level of plasma glial fibrillary acidic protein (ng/ml) between baseline and week 24.
Description
Glial fibrillary acidic protein is one of the main biomarkers of dementia
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the level of plasma neurofilament light chain (ng/ml) between baseline and week 24.
Description
Neurofilament light chain is one of the main biomarkers of dementia
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the level of plasma hyper-phosphorylated tau-181 (ng/ml) between baseline and week 24.
Description
Neurofilament light chain is one of the main biomarkers of dementia
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the P300 between baseline and week 24.
Description
P300 is the main indicator of EEG, and its normal value range is between 320 and 420.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the VP300 between baseline and week 24.
Description
VP300 is the main indicator of EEG, and its normal value range is between 320 and 420.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the MMN between baseline and week 24.
Description
MMN is the main indicator of EEG, and its normal value range is between 100 and 210.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the neurite density index between baseline and week 24.
Description
Neurite density index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the orientation dispersion index between baseline and week 24.
Description
Orientation dispersion index is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in the isotropic volume fraction between baseline and week 24.
Description
Isotropic volume fraction is the main indicator of neurite-oriented diffusion and density imaging (NODDI) .
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
The absolute change in theheart rate variability between baseline and week 24.
Description
The KARDi2/4-B autonomic nervous function mapping ECG system (Nanjing Left and Right Brain Biomedical Company, NeuroMed, China) will record and analyze millivolt-level signals of ECG oscillations, complete the frequency domain and time domain index detection of heart rate variability in 3 min, and generate an autonomic nervous function status step map.
Time Frame
Participants will be followed up for 24 weeks after baseline.
Other Pre-specified Outcome Measures:
Title
Whether the participants' vital signs were normal.
Description
Safety outcome
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
Whether the participants' Electrocardiograms were normal.
Description
Safety outcome
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
Whether the participants' Liver function were normal.
Description
Safety outcome
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
Whether the participants' kidney function were normal.
Description
Safety outcome
Time Frame
Participants will be followed up for 24 weeks after baseline.
Title
Severity of adverse events
Description
Safety outcome
Time Frame
Participants will be followed up for 24 weeks after baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria will be as follows:
Patients aged over 30;
Patients with orthostatic hypotension;
Patients who presence of subjective memory complaint
Patients who have objective evidence of cognitive impairment assessed using neurocognitive batteries
Patients who is not depressed;
Patients who have complete autonomy in daily living
Participants who score below normal on one or both of the tests (Montreal Cognitive Assessment: score of ≥18 to ≤26 or Mini-Mental State Examination score of ≥24 to ≤27)
Exclusion Criteria:
The exclusion criteria will be as follows:
Patients with secondary orthostatic hypotension;
Patients with dementia diagnosed according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders;
Patients allergic or contraindicated to Astragalus;
Patients who have been treated or have a history of stroke or transient ischemic attack, claustrophobia, bipolar disorder, schizophrenia, seizures, drug or alcohol abuse, malignancies, kidney failure and dialysis treatment, liver disease (hepatitis) and kidney disease;
Patients who refuse or have contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG) (pacemakers, coronary and peripheral artery stents, metal implants, claustrophobia, severe visual and/or hearing impairment);
Patients using a cholinesterase inhibitor, psychoactive drugs, medications that affect the cardiovascular system, or any medication known to interact with Astragalus;
Patients who are pregnant or lactating;
Patients who have participated in other clinical studies within the past 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Pan
Phone
86218341
Email
pxd77316@163.com
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Pan
Phone
86218341
Email
xieheyb@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy, Safety and Response Predictors of Adjuvant Astragalus for Cognition in Orthostatic Hypotension
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