Back to resultsExploring the Effect of Combined Chinese and Western Treatment on Home Medical Care
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring acupuncture, hypertension, elderly, home health care
Eligibility Criteria
Inclusion Criteria:
- patient with isolated blood pressure diagnosis by physicians and BP >140/<90 mmHg
- patient took the drug to control blood pressure for more than one year
- age>65 years old
- Willing to participate in this study
Exclusion Criteria:
- Suspected acute stroke
- chest pain or dyspnea
- ingestion of short-acting antihypertensive medication within 2 h prior to the beginning of the study
- body temperature >37.5∘C(99.5∘F)
Sites / Locations
- Taipei City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
drug use
drug combine acupuncture
Arm Description
routine drug use, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from ACE inhibitors, diuretics, and beta blockers
routine drug use combine acupuncture twice a week for 3 months
Outcomes
Primary Outcome Measures
blood pressure
measure blood pressure after the treatment compare the initial blood pressure
Secondary Outcome Measures
Traditional Chinese Medicine constitution
use The Constitution in Chinese Medicine Questionnaire
heart rate variability
use autonomic nervous system (ANS) watch to monitor patient's heart rate variability, Low Frequency/High Frequency ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03600220
Brief Title
Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care
Official Title
Effectiveness of Combining Antihypertensive Drugs and Acupuncture on Isolated Systolic Hypertension of Elderly Patients at Home
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City 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
combine antihypertensive drugs and acupuncture to isolated systolic hypertension elderly patients at home
Detailed Description
The investigators would like to compare the effectiveness of acupuncture and drug therapy on blood pressure.
The investigators chose acupuncture point according the Traditional Chinese Medicine theory, besides, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from angiotensin-converting enzyme inhibitor (ACE inhibitor), diuretics, and beta blockers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
acupuncture, hypertension, elderly, home health care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drug use
Arm Type
No Intervention
Arm Description
routine drug use, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from ACE inhibitors, diuretics, and beta blockers
Arm Title
drug combine acupuncture
Arm Type
Experimental
Arm Description
routine drug use combine acupuncture twice a week for 3 months
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
drug
Intervention Description
antihypertension drug, acupuncture twice a week for 3 months
Primary Outcome Measure Information:
Title
blood pressure
Description
measure blood pressure after the treatment compare the initial blood pressure
Time Frame
change from Baseline Systolic Blood Pressure at 3 months
Secondary Outcome Measure Information:
Title
Traditional Chinese Medicine constitution
Description
use The Constitution in Chinese Medicine Questionnaire
Time Frame
use the questionnaire at Baseline, 1.5 month, and three month later
Title
heart rate variability
Description
use autonomic nervous system (ANS) watch to monitor patient's heart rate variability, Low Frequency/High Frequency ratio
Time Frame
use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient with isolated blood pressure diagnosis by physicians and BP >140/<90 mmHg
patient took the drug to control blood pressure for more than one year
age>65 years old
Willing to participate in this study
Exclusion Criteria:
Suspected acute stroke
chest pain or dyspnea
ingestion of short-acting antihypertensive medication within 2 h prior to the beginning of the study
body temperature >37.5∘C(99.5∘F)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuei-Yu Huang
Organizational Affiliation
Taipei City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
12. IPD Sharing Statement
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Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care
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