ClinicalTrials.gg
Status unknownNCT04533269Updated Jan 8, 2021

A Study of Topical Arnica & Ledum on Bruise Reduction in HNV

An interventional study of Arnica montana, Ledum palustre in Bruise, Contusion, sponsored by Cearna, Inc.. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-08.

Sponsored by Cearna, Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bruise, Contusion

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03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's planned enrollment of 150 is above the median of 90 across 31 interventional studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

Cearna, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fitzpatrick skin type 1-3
  • 25 kg/m2
  • Self described bruisers
  • Intact skin in the target area, free of markings, blemishes and hair

Exclusion criteria

Exclusion Criteria:

  • Use of recreational drugs, , 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
  • Active wound or infection in the target area
  • History of keloids or hypertrophic scarring
  • History of collagen or vascular disease
  • History of organ transplant
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Active

    Arnica montana and Ledum palustre infused Pad

    Other: Arnica montana, Ledum palustre

  • Placebo comparator
    Placebo

    Pad (Matching appearance with Active)

    Other: Arnica montana, Ledum palustre

Interventions

  • OtherArnica montana, Ledum palustre

    Homeopathic

06

What researchers measure

Primary outcomes

  1. Efficacy

    Time to bruise healing in active vs. placebo

    Time frame: 11 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Aggregate data will be shared and published.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2021; primary completion for Oct 2022, 15 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2020
First posted
Aug 31, 2020
StartEst.
Jul 31, 2021
Primary completionEst.
Oct 31, 2022
CompletionEst.
Nov 30, 2022
Last update
Jan 8, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04533269
Lead sponsor
Cearna, Inc.
Responsible party
Sponsor
First posted
Aug 31, 2020
Start date
Jul 31, 2021 (estimated)
Primary completion
Oct 31, 2022 (estimated)
Completion
Nov 30, 2022 (estimated)
Last update
Jan 8, 2021

Study contacts

Jacqueline Blem
Contact
jacqui@cardiffclinical.com
858-945-6456

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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