Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. NCT02364349
  4. Details
NCT02364349 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02364349
Other study ID # JS-CT-2015-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2015
Est. completion date February 2015

Study information
Verified date November 2018
Source Jaseng Hospital of Korean Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 39 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bee Venom (BV)
Raw Bee Venom
• Essential Bee Venom (e-BV)
Bee venom without Hyaluronidase, Lysophospholipase, a-D-glucosidase, PLA2, Adolapin

Locations
Country Name City State
Korea, Republic of Jaseng Hospital of Korean Medicine Seoul Gangnam-Gu

Sponsors (1)
Lead Sponsor Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analog Scale(VAS) on Pain Visual Analog Scale on Pain 0.5 hours after intervention
Primary Wheal and erythema traced on adhesive, transparent films and measured with 0.01mm calipher 24 hours after intervention
Primary Visual Analog Scale(VAS) on Pain Visual Analog Scale on Pain 48 hours after intervention
Secondary Visual Analog Scale(VAS) on Pain Visual Analog Scale on Pain, 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention
Secondary Visual Analog Scale(VAS) for Wheal response Wheal response 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Secondary Visual Analog Scale(VAS) for Skin irritation Skin irritation 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Secondary Wheal and erythema traced on adhesive, transparent films and measured with 0.01mm calipher 0, 0.5, 6, 24, 72 hours after intervention
Secondary Adverse events General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue 0, 6, 24, 72 hours after intervention
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1