Acupuncture Therapy and Hypertension
ConditionMild to Moderate Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorUniversity of California, Irvine
About this trial
Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects from 45 to 75 years of age
Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.
Disqualifiers
Subjects will be excluded if pregnant or nursing.
Subjects will be excluded if they have coronary disease (by history or on ECG screening), conduction abnormalities on ECG consistent with left bundle branch block, cardiac arrhythmias associated with low blood pressure (<90 mmHg), peripheral vascular disease, orthopedic disease, diabetic neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness.
Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
Inability our or unwillingness of individual to give written informed consent.
Trial design
Design model
Factorial
Treatments tested in this trial
electroacupuncture
Other interventionacupuncture needling and stimulation are applied for 30 min
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: Anti-inflammatory EA (AI-EA)Experimental treatment 1 intervention
Group B: Sympathoinhibitory EA (SI-EA)Experimental treatment 1 intervention
Group C: Combined EA (cEA)Experimental treatment 1 intervention
Group D: Control EA (Sham-EA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in sympathetic and parasympathetic nervous systems
Heart rate variability and its component will be evaluated with EKG.
Time frame
through study completion, an average of 4.5 yearsSecondary outcomes
1
Change in biomarkers like cytokines
Plasma will be measured for inflammatory markers with ELISA kits.
Time frame
through study completion, an average of 4.5 yearsOther outcomes
1
Change in blood pressure
Blood pressure (systolic and diastolic) will be measured with an ambulatory blood pressure device every 20 min for 24 hours.
Time frame
through study completion, an average of 4.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Irvine
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov