Back to resultsUse of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Primary Purpose
Hypertension,Essential
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional basic science trial for Hypertension,Essential focused on measuring acupuncture, hypertension, targeted metabolome, pilot clinical trial
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture
Sham Acupuncture
Arm Description
Use real acupuncture treatment for blood pressure management in patients with hypertension
Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension
Outcomes
Primary Outcome Measures
24 hour ambulatory blood pressure
Secondary Outcome Measures
targeted plasma metabolome
Full Information
NCT ID
NCT03492892
First Posted
April 3, 2018
Last Updated
April 11, 2018
Sponsor
The University of Hong Kong
Collaborators
Chengdu University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03492892
Brief Title
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Official Title
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
August 19, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Chengdu University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
acupuncture, hypertension, targeted metabolome, pilot clinical trial
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Use real acupuncture treatment for blood pressure management in patients with hypertension
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Stimulate acupoint with filiform needles to restore the healthy condition of patients
Intervention Type
Device
Intervention Name(s)
Sham Acupuncture
Intervention Description
Stimulate non-acupoint with filiform needles to treat the condition of patients
Primary Outcome Measure Information:
Title
24 hour ambulatory blood pressure
Time Frame
up to week 6
Secondary Outcome Measure Information:
Title
targeted plasma metabolome
Time Frame
up to week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan-rong Liang, Prof.
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Patient Data will be shared upon request.
Learn more about this trial
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
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