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

Not Applicable

Completed

• Conditions: Hypertension,Essential
• Interventions: Device: Sham Acupuncture; Device: Acupuncture

• Registration Number: NCT03492892
• Lead Sponsor: The University of Hong Kong

Brief Summary

To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2016-08-19
• Study Completion: 2016-12-31
• Status Verified: 2018-04
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupuncture	Sham Acupuncture	Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension
Acupuncture	Acupuncture	Use real acupuncture treatment for blood pressure management in patients with hypertension

Primary Outcome Measures

Name	Time	Method
24 hour ambulatory blood pressure	up to week 6

Secondary Outcome Measures

Name	Time	Method
targeted plasma metabolome	up to week 6