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Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

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ClinicalTrials.gov Identifier: NCT03805035
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:

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. The best characterized mechanism of acupuncture analgesia is that acupuncture /electroacupuncture (EA) releases endogenous opioids, which then bind to their receptors.

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. Investigators will also investigate the mechanism of this analgesia-promoting effect in animal models.

The aims of the proposed studies are to: Aim-1: 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. Aim-2: Determine whether H1 receptor antagonists at relatively low doses facilitate EA analgesia in different animal pain models, such as inflammatory pain, orofacial pain, postoperative (incisional) pain, and neuropathic pain. Aim-3: Determine the site of action of antihistamine drugs, involving testing as to how H1 receptor antagonists facilitate the analgesic effects of EA. A series of pharmacologic studies will be conducted to clarify which neurotransmitters or receptors are associated with the effects of EA and H1 receptor antagonists.

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.


Condition or disease Intervention/treatment Phase
Pain Device: electroacupuncture Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate) Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate) Device: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research
Estimated Study Start Date : January 24, 2019
Estimated Primary Completion Date : April 29, 2019
Estimated Study Completion Date : April 29, 2019


Arm Intervention/treatment
Sham Comparator: sham EA group
Minimal needling at ST36 and GB34 (n=10)
Device: acupuncture
Minimal needling at ST36 and GB34
Other Name: shallow needling

Experimental: true EA group
EA at ST36 and GB34 (n=10)
Device: electroacupuncture
Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Active Comparator: EA+antihistamine(low dose) group
EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)
Device: electroacupuncture
Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)
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)
Other Name: chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)

Active Comparator: EA+antihistamine(high dose) group
EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)
Device: electroacupuncture
Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)
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)
Other Name: chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. . 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).
  2. . A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
  3. . An implant such as a pacemaker, defibrillator, or electronic medical equipment.
  4. . Pregnancy, or planning for pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805035


Contacts
Contact: Yi-Hung Chen, PhD +886-4-22053366 ext 3607 yihungchen@mail.cmu.edu.tw

Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Director: Yi-Hung Chen, PhD Graduate Institute of Acupuncture Science, China Medical University

Additional Information:
Publications:
Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03805035     History of Changes
Other Study ID Numbers: CMUH107-REC3-019
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:
Electroacupuncture (EA)
Antihistamine
Pain

Additional relevant MeSH terms:
Maleic acid
Histamine
Histamine phosphate
Chlorpheniramine
Dexchlorpheniramine
Histamine Antagonists
Histamine H1 Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Allergic Agents