NCT03600220

Brief Summary

combine antihypertensive drugs and acupuncture to isolated systolic hypertension elderly patients at home

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

July 26, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

June 25, 2018

Last Update Submit

July 24, 2018

Conditions

Hypertension

Keywords

acupuncture, hypertension, elderly, home health care

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    measure blood pressure after the treatment compare the initial blood pressure

    change from Baseline Systolic Blood Pressure at 3 months

Secondary Outcomes (2)

  • Traditional Chinese Medicine constitution

    use the questionnaire at Baseline, 1.5 month, and three month later

  • heart rate variability

    use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later

Study Arms (2)

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

Other: acupuncture

Interventions

acupunctureOTHER

antihypertension drug, acupuncture twice a week for 3 months

Also known as: drug
drug combine acupuncture

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Acupuncture TherapyPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Kuei-Yu Huang

    Taipei City Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 26, 2018

Study Start

June 1, 2018

Primary Completion

September 1, 2018

Study Completion

May 31, 2019

Last Updated

July 26, 2018

Record last verified: 2018-06

Locations

TW(1)