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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT03492892

Collaborator

Chengdu University of Traditional Chinese Medicine (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2012

Actual Primary Completion Date :

Aug 19, 2016

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

24 hour ambulatory blood pressure [up to week 6]

Secondary Outcome Measures

targeted plasma metabolome [up to week 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.