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

NCT03492892 | Completed

• 1 other identifier: 2012KL-003
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension,Essential

Keywords

acupuncture; hypertension; targeted metabolome; pilot clinical trial

Outcome Measures

Primary Outcomes (1)

• 24 hour ambulatory blood pressure

  up to week 6

Secondary Outcomes (1)

• targeted plasma metabolome

  up to week 6

Study Arms (2)

Acupuncture

EXPERIMENTAL

Use real acupuncture treatment for blood pressure management in patients with hypertension

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension

Device: Sham Acupuncture

Interventions

Acupuncture DEVICE

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

Acupuncture

Sham Acupuncture DEVICE

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

Sham Acupuncture

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chengdu University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Fan-rong Liang, Prof.

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: January 1, 2012
• Primary Completion: August 19, 2016
• Study Completion: December 31, 2016
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share