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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Hypertension,Essential

Treatments

Device: Acupuncture
Device: Sham Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03492892
2012KL-003

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Acupuncture
Experimental group
Description:
Use real acupuncture treatment for blood pressure management in patients with hypertension
Treatment:
Device: Acupuncture
Sham Acupuncture
Sham Comparator group
Description:
Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension
Treatment:
Device: Sham Acupuncture

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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