Clinical trial NCT03492892: Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Official title: Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Keywords: acupuncture
hypertension
targeted metabolome
pilot clinical trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chengdu University of Traditional Chinese Medicine
First posted: 2018-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24 hour ambulatory blood pressure
timeFrame: up to week 6
Secondary outcomes:
measure: targeted plasma metabolome
timeFrame: up to week 6
Other outcomes:
Locations:
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Fan-rong Liang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: