NCT02364349

Brief Summary

This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

January 28, 2015

Last Update Submit

November 5, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale(VAS) on Pain

    Visual Analog Scale on Pain

    0.5 hours after intervention

  • Wheal and erythema

    traced on adhesive, transparent films and measured with 0.01mm calipher

    24 hours after intervention

  • Visual Analog Scale(VAS) on Pain

    Visual Analog Scale on Pain

    48 hours after intervention

Secondary Outcomes (5)

  • Visual Analog Scale(VAS) on Pain

    0, 2, 6, 24, 72, 96, 120, 144 hours after intervention

  • Visual Analog Scale(VAS) for Wheal response

    0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention

  • Visual Analog Scale(VAS) for Skin irritation

    0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention

  • Wheal and erythema

    0, 0.5, 6, 24, 72 hours after intervention

  • Adverse events

    0, 6, 24, 72 hours after intervention

Study Arms (2)

Bee Venom (BV) group

ACTIVE COMPARATOR

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)

essential Bee Venom (eBV) group

EXPERIMENTAL

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)

Interventions

Bee Venom (BV)DRUG

Raw Bee Venom

Also known as: Bee Venom pharmacopuncture, Bee Venom injection
Bee Venom (BV) group
Essential Bee Venom (e-BV)DRUG

Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin

Also known as: Essential Bee Venom pharmacopuncture, Essential Bee Venom injection
essential Bee Venom (eBV) group

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Interventions

Bee Venoms

Intervention Hierarchy (Ancestors)

Arthropod VenomsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Joon-Shik SHIN, MD

    Jaseng Hospital of Korean Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 18, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 7, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)