Bruise, ContusionNCT04533269
A Study of Topical Arnica & Ledum on Bruise Reduction in HNV
A study testing Arnica montana, Ledum palustre in people with Bruise, Contusion, run by Cearna, Inc..
Trial summary
Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruise, Contusion
- What is being tested?
- Arnica montana, Ledum palustre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2021to 30 Nov 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin type 1-3
- BMI 25 kg/m2
- Self described bruisers
- Intact skin in the target area, free of markings, blemishes and hair
Who cannot join
- Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
- Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
- Inability to forego application of topical products in the target area
- Hair removal by laser, wax or chemicals within one week prior to Day 1
- Avoid tanning beds
- History of allergy to topical gels, Arnica or Ledum
Show all 10Show fewer
- Active wound or infection in the target area
- History of keloids or hypertrophic scarring
- History of collagen or vascular disease
- History of organ transplant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Arnica Montana and Ledum Palustre Formulation on Mechanically Induced Bruising in Healthy Normal Volunteers
Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. The trial will be conducted at 5-8 sites with up to 150 subjects. Each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. Subjects and study investigators will be blinded to the order of treatment assignment. Subjects will be asked to come to the clinic for photographic assessments of the bruise. Each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on Day 1. The pad will be applied by study staff immediately after bruise induction (within 5 minutes). The pad will cover the bruised area completely, and then sealed with Tegaderm. All procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. All photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.
- Conditions
- Bruise, Contusion
- Being tested
- Arnica montana, Ledum palustre
- Medical subject headings
- Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnica montana, Ledum palustreOther
Homeopathic
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Arnica montana and Ledum palustre infused Pad Receives: Other: Arnica montana, Ledum palustre |
| Placebo | Placebo comparator | Pad (Matching appearance with Active) Receives: Other: Arnica montana, Ledum palustre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Time to bruise healing in active vs. placebo
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start31 Jul 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bruise, ContusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cearna, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533269
- Sponsor's protocol ID
- CI-B001
- Status last verified
- Nov 2020
- First submitted
- 24 Aug 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared and published.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Arnica Montana and Ledum Palustre Formulation on Mechanically Induced Bruising in Healthy Normal Volunteers
- ClinicalTrials.gov ID
- NCT04533269
- Acronym / sponsor ID
- CI-B001
- Conditions
- Bruise, Contusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cearna, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 31 Aug 2020 (actual)
- 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.
Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing.
Detailed description
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. The trial will be conducted at 5-8 sites with up to 150 subjects. Each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. Subjects and study investigators will be blinded to the order of treatment assignment. Subjects will be asked to come to the clinic for photographic assessments of the bruise. Each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on Day 1. The pad will be applied by study staff immediately after bruise induction (within 5 minutes). The pad will cover the bruised area completely, and then sealed with Tegaderm. All procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. All photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Arnica montana, Ledum palustreArnica montana and Ledum palustre infused Pad |
| Placebo | Placebo comparator | Other: Arnica montana, Ledum palustrePad (Matching appearance with Active) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fitzpatrick skin type 1-3
- BMI 25 kg/m2
- Self described bruisers
- Intact skin in the target area, free of markings, blemishes and hair
Key exclusion criteria (10 listed)
- Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
- Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
- Inability to forego application of topical products in the target area
- Hair removal by laser, wax or chemicals within one week prior to Day 1
- Avoid tanning beds
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 |
|---|---|---|
| Arnica montana, Ledum palustreHomeopathic | Other | Active, Placebo |
Primary outcome
Efficacy
Time frame: 11 days
Time to bruise healing in active vs. placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No. Aggregate data will be shared and published.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arnica montana, Ledum palustre in people with Bruise, Contusion, run by Cearna, Inc..
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 10 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Blem (858-945-6456, jacqui@cardiffclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 11 days). 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 8 Jan 2021.