Exploring the Effect of Combined Chinese and Western Treatment on Home Medical Care

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

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: acupuncture

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: drug use; routine drug use, each patient was using 1-3 antihypertensive drug of a heterogeneous pharmacological group ranging from ACE inhibitors, diuretics, and beta blockers
Experimental: drug combine acupuncture; routine drug use combine acupuncture twice a week for 3 months	Other: acupuncture; antihypertension drug, acupuncture twice a week for 3 months; Other Names: drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	measure blood pressure after the treatment compare the initial blood pressure	change from Baseline Systolic Blood Pressure at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine constitution	use The Constitution in Chinese Medicine Questionnaire	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	use ANS watch to monitor patient's condition at Baseline, 1.5 month, and three month later

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Study Director: Kuei-Yu Huang, Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: acupuncture, hypertension, elderly, home health care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: TCHIRB-10703120-E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No