Hypertension,EssentialNCT03492892
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
A study testing Acupuncture in people with Hypertension,Essential, run by The University of Hong Kong.
Trial summary
To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.
Read the 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.
- Conditions
- Hypertension,Essential
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- acupuncture, hypertension, targeted metabolome, pilot clinical trial
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Stimulate acupoint with filiform needles to restore the healthy condition of patients
Sham AcupunctureDevice
Stimulate non-acupoint with filiform needles to treat the condition of patients
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Use real acupuncture treatment for blood pressure management in patients with hypertension Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | Use non-acupoint as the stimulating site in acupuncture for the treatment of hypertension Receives: Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour ambulatory blood pressure
Measured: up to week 6
Secondary outcomes (1)
targeted plasma metabolome
Measured: up to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Jan 2012
- Primary completion19 Aug 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Fan-rong Liang, Prof., Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492892
- Sponsor's protocol ID
- 2012KL-003
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives
- ClinicalTrials.gov ID
- NCT03492892
- Acronym / sponsor ID
- 2012KL-003
- Conditions
- Hypertension,Essential
- Keywords
- acupuncture, hypertension, targeted metabolome, pilot clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 19 Aug 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureUse real acupuncture treatment for blood pressure management in patients with hypertension |
| Sham Acupuncture | Sham comparator | Device: Sham AcupunctureUse non-acupoint as the stimulating site in acupuncture for the treatment of hypertension |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureStimulate acupoint with filiform needles to restore the healthy condition of patients | Device | Acupuncture |
| Sham AcupunctureStimulate non-acupoint with filiform needles to treat the condition of patients | Device | Sham Acupuncture |
Primary outcome
24 hour ambulatory blood pressure
Time frame: up to week 6
1 secondary outcome
targeted plasma metabolome
Time frame: up to week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: No. Individual Patient Data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan-rong Liang, Prof. principal investigator
Chengdu University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Hypertension,Essential, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour ambulatory blood pressure (time frame: up to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.