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Completed

NCT Number: NCT03492892

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

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

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture

Device

Stimulate acupoint with filiform needles to restore the healthy condition of patients

Sham acupuncture

Device

Stimulate non-acupoint with filiform needles to treat the condition of patients

Primary outcomes

  1. 24 hour ambulatory blood pressure

    Time frame: up to week 6

Secondary outcomes

  1. targeted plasma metabolome

    Time frame: up to week 6

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2018
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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