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

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492892
• Other study ID #: 2012KL-003
• Status: Completed
• Phase: N/A
• First received: April 3, 2018
• Last updated: April 11, 2018
• Start date: January 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2016
• Est. primary completion date: August 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension,Essential

Intervention

Device:
• Acupuncture
Stimulate acupoint with filiform needles to restore the healthy condition of patients
• Sham Acupuncture
Stimulate non-acupoint with filiform needles to treat the condition of patients

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Chengdu University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour ambulatory blood pressure		up to week 6
Secondary	targeted plasma metabolome		up to week 6