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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT011306 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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 age. 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, 39 participants have been enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-inflammatory EA (AI-EA) | Experimental | Anti-inflammatory electroacupuncture therapy |
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| Sympathoinhibitory EA (SI-EA) | Experimental | sympatho-inhibitory electroacupuncture therapy |
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| Combined EA (cEA) | Experimental | combination of SI-EA and AI-EA |
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| Control EA (Sham-EA) | Experimental | Sham electroacupuncture |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Other | acupuncture needling and stimulation are applied for 30 min |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in biomarkers like cytokines | Plasma will be measured for inflammatory markers with ELISA kits. | through study completion, an average of 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashwini Erande | Contact | 7144567025 | aerande@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shaista Malik | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Susan Samueli Integrative Health Institute | Recruiting | Irvine | California | 92697 | United States |
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| Label | URL |
|---|---|
| clinical study | View source |
| animal study | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
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two by two factorial design for a 4 arm study.
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The pharmacologist who assays the plasma and serum is masked in the study.
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| University of California, Irvine, Health Sciences Medical Center | Recruiting | Orange | California | 92868 | United States |
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| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |