HypertensionNCT03600220
Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care
A study testing acupuncture in people with Hypertension, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
combine antihypertensive drugs and acupuncture to isolated systolic hypertension elderly patients at home Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 31 May 2019
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Combining Antihypertensive Drugs and Acupuncture on Isolated Systolic Hypertension of Elderly Patients at Home
combine antihypertensive drugs and acupuncture to isolated systolic hypertension elderly patients at home
Read the 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.
- Conditions
- Hypertension
- Being tested
- acupuncture
- Keywords
- acupuncture, hypertension, elderly, home health care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called drug
antihypertension drug, acupuncture twice a week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| drug use | No intervention | routine drug use, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from ACE inhibitors, diuretics, and beta blockers |
| drug combine acupuncture | Experimental | routine drug use combine acupuncture twice a week for 3 months Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
measure blood pressure after the treatment compare the initial blood pressure
Measured: change from Baseline Systolic Blood Pressure at 3 months
Secondary outcomes (2)
Traditional Chinese Medicine constitution
use The Constitution in Chinese Medicine Questionnaire
Measured: use the questionnaire at Baseline, 1.5 month, and three month later
heart rate variability
use autonomic nervous system (ANS) watch to monitor patient's heart rate variability, Low Frequency/High Frequency ratio
Measured: use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion31 May 2019 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kuei-Yu Huang, Study director, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600220
- Sponsor's protocol ID
- TCHIRB-10703120-E
- Status last verified
- Jun 2018
- First submitted
- 25 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combining Antihypertensive Drugs and Acupuncture on Isolated Systolic Hypertension of Elderly Patients at Home
- ClinicalTrials.gov ID
- NCT03600220
- Acronym / sponsor ID
- TCHIRB-10703120-E
- Conditions
- Hypertension
- Keywords
- acupuncture, hypertension, elderly, home health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 26 Jul 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug use | No intervention | –routine drug use, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from ACE inhibitors, diuretics, and beta blockers |
| drug combine acupuncture | Experimental | Other: acupunctureroutine drug use combine acupuncture twice a week for 3 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: drugantihypertension drug, acupuncture twice a week for 3 months | Other | drug combine acupuncture |
Primary outcome
blood pressure
Time frame: change from Baseline Systolic Blood Pressure at 3 months
measure blood pressure after the treatment compare the initial blood pressure
2 secondary outcomes
Traditional Chinese Medicine constitution
Time frame: use the questionnaire at Baseline, 1.5 month, and three month later
heart rate variability
Time frame: use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Kuei-Yu Huang study director
Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Hypertension, run by Taipei City Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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 26 Jul 2018. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: change from Baseline Systolic Blood Pressure at 3 months). 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 26 Jul 2018.