NCT07664826

Brief Summary

The gag reflex relief effect of acupuncture of CV24 acupoint will be compared to acupuncture of PC6 and K3 acupoints in healthy volunteers in crossover mode. Second step will be the investigation whether local anesthesia using EMLA creme will block the gag relief effect of CV24 acupuncture in healthy volunteers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 8, 2026

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of saliva injector insertion (cm)

    Saliva injector is inserted intraoral slowly until the gagging (pharyngeal reflex) is elicited; the length of insertion of saliva injector will be measured in centimeters

    Day 1 ( before and after acupuncture)

Secondary Outcomes (1)

  • Severity of gagging, measured using the Numeric Rating Scale NRS-11 (0=no gagging; 10=maximal)

    Day 1 ( before and after acupuncture)

Study Arms (3)

CV24

EXPERIMENTAL

Needling of acupoint PC6

Other: Acupuncture

PC6

ACTIVE COMPARATOR

Needling of acupoint PC6

Other: Acupuncture

K3

ACTIVE COMPARATOR

Needling of acupoint K3

Other: Acupuncture

Interventions

Needling of acupoints CV24, PC6 and K3

CV24K3PC6

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers aged between 20-40 years old with an American Society of Anesthesiologists physical status of I to II naïve to acupuncture
  • Participants without previous opioid and psychotropic medication
  • Without use of recreational drugs 3 days prior to study sessions
  • Without systemic disease or local skin lesions at the sites of acupuncture
  • Without drug allergy to local anesthetics, especially EMLA preparation
  • Participants who have given written informed consent

You may not qualify if:

  • Local skin infection at the sites of acupuncture
  • Aged \< 20 or \> 35 years
  • History of drug allergy to local anesthetics
  • Participants who are unable to understand the consent form or to use numeric rating scale NRS-11
  • Discontinuation Criteria
  • Any adverse effects during study session
  • In case of local or systemic infection
  • In case if subject will withdraw from participation in this study at any time, for any reason, specified or non-specified, and without penalty or loss of benefits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Taras I Usichenko, Prof. Dr. med., MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 24, 2026

Study Start

January 21, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Corresponding author will share the anonymized, statistically calculated data on request after publication of the results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publication of study results
Access Criteria
On request via email contact to the corresponding author

Locations