Healthy VolunteersPhase 1NCT02364349
A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
A Phase 1 study testing Bee Venom (BV) and Essential Bee Venom (e-BV) in people with Healthy Volunteers, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bee Venom (BV) and Essential Bee Venom (e-BV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Bee Venom (BV), Essential Bee Venom (e-BV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom (BV)Drug
Also called Bee Venom pharmacopuncture, Bee Venom injection
Raw Bee Venom
Essential Bee Venom (e-BV)Drug
Also called Essential Bee Venom pharmacopuncture, Essential Bee Venom injection
Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Essential Bee Venom (e-BV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS) on Pain
Visual Analog Scale on Pain
Measured: 0.5 hours after intervention
Wheal and erythema
traced on adhesive, transparent films and measured with 0.01mm calipher
Measured: 24 hours after intervention
Visual Analog Scale(VAS) on Pain
Visual Analog Scale on Pain
Measured: 48 hours after intervention
Secondary outcomes (5)
Visual Analog Scale(VAS) on Pain
Visual Analog Scale on Pain,
Measured: 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention
Visual Analog Scale(VAS) for Wheal response
Wheal response
Measured: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Visual Analog Scale(VAS) for Skin irritation
Skin irritation
Measured: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Wheal and erythema
traced on adhesive, transparent films and measured with 0.01mm calipher
Measured: 0, 0.5, 6, 24, 72 hours after intervention
Adverse events
General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue
Measured: 0, 6, 24, 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joon-Shik SHIN, MD, Study chair, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364349
- Sponsor's protocol ID
- JS-CT-2015-01
- Status last verified
- Nov 2018
- First submitted
- 28 Jan 2015
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
- ClinicalTrials.gov ID
- NCT02364349
- Acronym / sponsor ID
- JS-CT-2015-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bee Venom (BV) group | Active comparator | Drug: Bee Venom (BV)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. |
| essential Bee Venom (eBV) group | Experimental | Drug: Essential Bee Venom (e-BV)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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bee Venom (BV)Also: Bee Venom pharmacopuncture, Bee Venom injectionRaw Bee Venom | Drug | Bee Venom (BV) group |
| Essential Bee Venom (e-BV)Also: Essential Bee Venom pharmacopuncture, Essential Bee Venom injectionBee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin | Drug | essential Bee Venom (eBV) group |
Primary outcome
Visual Analog Scale(VAS) on Pain
Time frame: 0.5 hours after intervention
Visual Analog Scale on Pain
Wheal and erythema
Time frame: 24 hours after intervention
traced on adhesive, transparent films and measured with 0.01mm calipher
Visual Analog Scale(VAS) on Pain
Time frame: 48 hours after intervention
Visual Analog Scale on Pain
5 secondary outcomes
Visual Analog Scale(VAS) on Pain
Time frame: 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
Visual Analog Scale(VAS) for Skin irritation
Time frame: 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
Adverse events
Time frame: 0, 6, 24, 72 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon-Shik SHIN, MD study chair
Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bee Venom (BV) and Essential Bee Venom (e-BV) in people with Healthy Volunteers, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) on Pain (time frame: 0.5 hours after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.