PainNCT03805035

Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

A study testing electroacupuncture, antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate) and antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate) in people with Pain, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: electroacupuncture, antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate) and antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteTaiwan
Study dates: 24 Jan 2019to 30 Jun 2019
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 20 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

. Age: 20 to 30 years of age.
. Agrees to undergo a comprehensive medical history and physical examination.
. No history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment.

Who cannot join

. An ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy).
. A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
. An implant such as a pacemaker, defibrillator, or electronic medical equipment.
. Pregnancy, or planning for pregnancy.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

China Medical University Hospital
Taichung, 404

Other trials in Taiwan

About this study

Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is increasingly practiced worldwide. The effects of acupuncture in chronic pain have been investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for treating allergy. Recently, investigators found that histamine H1 receptor antagonists at relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing test. Investigators aim to further explore whether histamine H1 receptor antagonists also facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36 and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain threshold. It is expected that the completion of this proposed study will enhance our knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a low dose and help to define its application for clinical use.

Conditions: Pain
Being tested: electroacupuncture, antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate), antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate), acupuncture
Keywords: Electroacupuncture (EA), Antihistamine, Pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

electroacupunctureDevice
Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)Drug
Also called chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)
Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)Drug
Also called chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)
Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
acupunctureDevice
Also called shallow needling
Minimal needling at ST36 and GB34

Study groups in NCT03805035
Study group	Role	What they receive
sham EA group	Sham comparator	Minimal needling at ST36 and GB34 (n=10) Receives: Device: acupuncture
true EA group	Experimental	EA at ST36 and GB34 (n=10) Receives: Device: electroacupuncture
EA+antihistamine(low dose) group	Active comparator	EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10) Receives: Device: electroacupuncture; Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)
EA+antihistamine(high dose) group	Active comparator	EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10) Receives: Device: electroacupuncture; Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)

What is being measured

The primary outcome is the main question the study is designed to answer.

pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)
Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.
Measured: baseline and 10min after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 201930 Jun 2019

First posted15 Jan 2019
Study start24 Jan 2019
Primary completion27 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by China Medical University HospitalThe 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03805035
Sponsor's protocol ID: CMUH107-REC3-019
Status last verified: Jan 2020
First submitted: 8 Jan 2019
Last updated: 9 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. doi: 10.1111/j.1471-4159.1992.tb08903.x.
PubMed 1351926
Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. doi: 10.1016/j.neulet.2003.09.080.
PubMed 14698480
Lee YC, Tu CH, Chung HY, Luo ST, Chu YT, MacDonald IJ, Kotha P, Huang CC, Lane HY, Lin JG, Chen YH. Antihistamine promotes electroacupuncture analgesia in healthy human subjects: A pilot study. J Tradit Complement Med. 2022 Apr 21;12(5):511-517. doi: 10.1016/j.jtcme.2022.04.003. eCollection 2022 Sep.
PubMed 36081814

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research
ClinicalTrials.gov ID: NCT03805035
Acronym / sponsor ID: CMUH107-REC3-019
Conditions: Pain
Keywords: Electroacupuncture (EA), Antihistamine, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: China Medical University HospitalUniversity, hospital or other
Study start: 24 Jan 2019 (actual)
Primary completion: 27 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 15 Jan 2019 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
sham EA group	Sham comparator	Device: acupunctureMinimal needling at ST36 and GB34 (n=10)
true EA group	Experimental	Device: electroacupunctureEA at ST36 and GB34 (n=10)
EA+antihistamine(low dose) group	Active comparator	Device: electroacupuncture, Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)
EA+antihistamine(high dose) group	Active comparator	Device: electroacupuncture, Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)

Who may qualify

Ages: 20 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

. Age: 20 to 30 years of age.
. Agrees to undergo a comprehensive medical history and physical examination.
. No history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment.

Key exclusion criteria (4 listed)

. An ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy).
. A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
. An implant such as a pacemaker, defibrillator, or electronic medical equipment.
. Pregnancy, or planning for pregnancy.

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
electroacupunctureGroup 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)	Device	EA+antihistamine(high dose) group, EA+antihistamine(low dose) group, true EA group
antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)Also: chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)	Drug	EA+antihistamine(low dose) group
antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)Also: chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)	Drug	EA+antihistamine(high dose) group
acupunctureAlso: shallow needlingMinimal needling at ST36 and GB34	Device	sham EA group

Primary outcome

pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)
Time frame: baseline and 10min after treatment
Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.

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 9 Jan 2020.
Background: PubMed 1351926Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. doi: 10.1111/j.1471-4159.1992.tb08903.x.
Background: PubMed 14698480Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. doi: 10.1016/j.neulet.2003.09.080.
Derived from this study: PubMed 36081814Lee YC, Tu CH, Chung HY, Luo ST, Chu YT, MacDonald IJ, Kotha P, Huang CC, Lane HY, Lin JG, Chen YH. Antihistamine promotes electroacupuncture analgesia in healthy human subjects: A pilot study. J Tradit Complement Med. 2022 Apr 21;12(5):511-517. doi: 10.1016/j.jtcme.2022.04.003. eCollection 2022 Sep.
Individual participant dataSharing planned: No

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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.

Yi-Hung Chen, PhD study director

Graduate Institute of Acupuncture Science, China Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES) (time frame: baseline and 10min after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805035, which also lists 3 linked publications.

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 9 Jan 2020.