A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture

November 5, 2018 updated by: Jaseng Hospital of Korean Medicine
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This double-blinded randomized clinical trial investigates difference in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Twenty healthy volunteers aged 20-40 years were randomly allocated to the 2 groups and administered eBV and BV on left and right forearm, respectively, in accordance with group allocation. Physician, participant, and outcome assessor were blinded to group allocation. Local pain, swelling, itching, redness, wheals and adverse reactions were recorded by timepoint before and after treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
        • Jaseng Hospital of Korean Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with no prior exposure to bee venom treatment
  • Healthy individuals of both genders, 20 to 39 years old
  • Individuals able to communicate their thoughts
  • Voluntary participants who have provided written consent

Exclusion Criteria:

  • Individuals on medications for chronic diseases (i.e. hypertension, hyperlipidemia)
  • Individuals with past history of allergic dermatitis
  • Individuals with past history of adverse events following bee stings
  • Individuals with symptoms of common cold
  • Individuals with fear of bee venom intervention or those who refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bee Venom (BV) group
All subjects are injected with Bee Venom (BV, intervention), randomly assigned to the right or left forearm. Raw BV used dried BV prepared through collection from bee venom sacs and removal of impurities. The BV administration site on each subject was on the palmar side of the designated arm 5 cm below the middle of the elbow crease as it is convenient for observation and has high responsiveness. Pharmacopuncture sessions were also conducted in the morning for higher responsiveness.
Drug: Bee Venom (BV)
Raw Bee Venom
Other Names:
  • Bee Venom pharmacopuncture
  • Bee Venom injection
Experimental: essential Bee Venom (eBV) group
All subjects are injected with essential Bee Venom (eBV, intervention), randomly assigned to the right or left forearm. eBV was prepared through the following methods: BV was collected from bee venom sacs and dried. LC/MS was used to analyze subdivisions of dried BV dissolved in purified water and passed through a sephadex G-25 column to collect histamine-free units. Collected units were filtered to eliminate allergenic substances including PLA2 of molecular weight 10 kDa or higher. The eBV administration site on each subject was on the palmar side of the designated arm 5 cm below the middle of the elbow crease as it is convenient for observation and has high responsiveness. Pharmacopuncture sessions were also conducted in the morning for higher responsiveness.
Drug: Essential Bee Venom (e-BV)
Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin
Other Names:
  • Essential Bee Venom pharmacopuncture
  • Essential Bee Venom injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale(VAS) on Pain
Time Frame: 0.5 hours after intervention
Visual Analog Scale on Pain
0.5 hours after intervention
Wheal and erythema
Time Frame: 24 hours after intervention
traced on adhesive, transparent films and measured with 0.01mm calipher
24 hours after intervention
Visual Analog Scale(VAS) on Pain
Time Frame: 48 hours after intervention
Visual Analog Scale on Pain
48 hours after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale(VAS) on Pain
Time Frame: 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention
Visual Analog Scale on Pain,
0, 2, 6, 24, 72, 96, 120, 144 hours after intervention
Visual Analog Scale(VAS) for Wheal response
Time Frame: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Wheal response
0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Visual Analog Scale(VAS) for Skin irritation
Time Frame: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Skin irritation
0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Wheal and erythema
Time Frame: 0, 0.5, 6, 24, 72 hours after intervention
traced on adhesive, transparent films and measured with 0.01mm calipher
0, 0.5, 6, 24, 72 hours after intervention
Adverse events
Time Frame: 0, 6, 24, 72 hours after intervention
General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue
0, 6, 24, 72 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Hospital of Korean Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Joon-Shik SHIN, MD, Jaseng Hospital of Korean Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-CT-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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