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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03600220
Other study ID # TCHIRB-10703120-E
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date May 31, 2019

Study information

Verified date June 2018
Source Taipei City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date May 31, 2019
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

1. patient with isolated blood pressure diagnosis by physicians and BP >140/<90 mmHg

2. patient took the drug to control blood pressure for more than one year

3. age>65 years old

4. Willing to participate in this study

Exclusion Criteria:

1. Suspected acute stroke

2. chest pain or dyspnea

3. ingestion of short-acting antihypertensive medication within 2 h prior to the beginning of the study

4. body temperature >37.5°C(99.5°F)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
acupuncture
antihypertension drug, acupuncture twice a week for 3 months

Locations

Country Name City State
Taiwan Taipei City Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood pressure measure blood pressure after the treatment compare the initial blood pressure change from Baseline Systolic Blood Pressure at 3 months
Secondary Traditional Chinese Medicine constitution use The Constitution in Chinese Medicine Questionnaire use the questionnaire at Baseline, 1.5 month, and three month later
Secondary heart rate variability use autonomic nervous system (ANS) watch to monitor patient's heart rate variability, Low Frequency/High Frequency ratio use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later
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