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NCT Number: NCT02364349

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

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

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Key information

Conditions

Healthy Volunteers

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jaseng Hospital of Korean Medicine

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bee Venom (BV)

Drug

Raw Bee Venom

Other names: Bee Venom pharmacopuncture, Bee Venom injection

Essential Bee Venom (e-BV)

Drug

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

Other names: Essential Bee Venom pharmacopuncture, Essential Bee Venom injection

Primary outcomes

  1. Visual Analog Scale(VAS) on Pain

    Time frame: 0.5 hours after intervention

    Visual Analog Scale on Pain

  2. Wheal and erythema

    Time frame: 24 hours after intervention

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

  3. Visual Analog Scale(VAS) on Pain

    Time frame: 48 hours after intervention

    Visual Analog Scale on Pain

Secondary outcomes

  1. Visual Analog Scale(VAS) on Pain

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

    Visual Analog Scale on Pain,

  2. 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

  3. 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

  4. 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

  5. Adverse events

    Time frame: 0, 6, 24, 72 hours after intervention

    General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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