Acupuncture Therapy and Hypertension

Mild to Moderate Hypertension Clinical Trial

Official title:

Acupuncture Therapy in Non Medicated Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530512
• Other study ID #: 19992222
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: June 2023
• Source: University of California, Irvine
• Contact: Ashwini Erande
• Phone: 7144567025
• Email: aerande[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will not be on hypertensive medications. The course last for 8 weeks and the frequency is once a week.

Description:

Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age1,2. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.

The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity [sympathoinhibitory (SI)], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers [thus anti-inflammatory (AI)] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 12 participants have been enrolled in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects from 50 to 75 years of age

2. Clinically diagnosed with mild to moderate hypertension and NOT on medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and

3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Exclusion Criteria:

1. Subjects will be excluded if on anti-hypertensive medications.

2. Subjects will be excluded if pregnant or nursing.

3. 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.

4. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.

5. Inability our or unwillingness of individual to give written informed consent.

Related Conditions & MeSH terms

• Hypertension
• Mild to Moderate Hypertension

Intervention

Other:
• electroacupuncture
acupuncture needling and stimulation are applied for 30 min

Locations

Country	Name	City	State
United States	Susan Samueli Integrative Health Institute	Irvine	California
United States	University of California, Irvine, Health Sciences Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood pressure	Blood pressure (systolic and diastolic) will be measured with an ambulatory blood pressure device every 20 min for 24 hours.	through study completion, an average of 4.5 years
Primary	Changes in sympathetic and parasympathetic nervous systems	Heart rate variability and its component will be evaluated with EKG.	through study completion, an average of 4.5 years
Secondary	Change in biomarkers like cytokines	Plasma will be measured for inflammatory markers with ELISA kits.	through study completion, an average of 4.5 years