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

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ClinicalTrials.gov Identifier: NCT03492892
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Chengdu University of Traditional Chinese Medicine
Information provided by (Responsible Party):
The University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Hypertension,Essential Device: Acupuncture Device: Sham Acupuncture Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : August 19, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Use real acupuncture treatment for blood pressure management in patients with hypertension
Device: Acupuncture
Stimulate acupoint with filiform needles to restore the healthy condition of patients

Sham Comparator: Sham Acupuncture
Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension
Device: Sham Acupuncture
Stimulate non-acupoint with filiform needles to treat the condition of patients




Primary Outcome Measures :
  1. 24 hour ambulatory blood pressure [ Time Frame: up to week 6 ]

Secondary Outcome Measures :
  1. targeted plasma metabolome [ Time Frame: up to week 6 ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492892


Sponsors and Collaborators
The University of Hong Kong
Chengdu University of Traditional Chinese Medicine
Investigators
Principal Investigator: Fan-rong Liang, Prof. Chengdu University of Traditional Chinese Medicine

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03492892     History of Changes
Other Study ID Numbers: 2012KL-003
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Patient Data will be shared upon request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong:
acupuncture
hypertension
targeted metabolome
pilot clinical trial

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents