Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives

Study Overview
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Brief Summary
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To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Detailed Description
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Acupuncture has been widely used for blood pressure management. Its effect on the cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Official Title
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Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives

Conditions
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Hypertension,Essential

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 45 and 75 years; were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history; without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases; the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4; didn't administer any drugs or herbs in at 15 days before the start of the study; didn't participate in any study other than this; agreed to cooperate with researchers in all research procedures after they were introduced this study; and provided with written informed consent. Exclusion Criteria: age≤45 or age≥75; with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension; had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic; accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.; with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72); pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year; with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen; with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders; alcoholics or drug abusers, or vegetarians; used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis; used to administer any drug that may potentially impaired renal or hepatic function; with cardiovascular disease that had been treated with acupuncture within recent three months; or undergoing other clinical trials.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Use real acupuncture treatment for blood pressure management in patients with hypertension | Device: Acupuncture<br>* Stimulate acupoint with filiform needles to restore the healthy condition of patients<br>|
| Sham Comparator: Sham Acupuncture<br>Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension | Device: Sham Acupuncture<br>* Stimulate non-acupoint with filiform needles to treat the condition of patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour ambulatory blood pressure |  | up to week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| targeted plasma metabolome |  | up to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, hypertension, targeted metabolome, pilot clinical trial