Wound HealingNCT03586232
Arnica Montana and Bromelain in Rhinoplasty
A study testing Arnica Montana and Bromelain in people with Wound Healing, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the perioperative use of Arnica Montana and the combined use of Arnica Montana and Bromelain in aiding the body's wound healing functions during the postoperative period after rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Arnica Montana and Bromelain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2019to Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -adults scheduled for outpatient primary rhinoplasty with osteotomies at Boston Medical Center
Who cannot join
- oral or contact allergies to Arnica Montana or to derivatives from the Ananas comosus or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies or Bromelain as determined by self disclosure.
- allergies to pineapple as Bromelain is from pineapple extract
- currently taking antiplatelet medication or anticoagulation medications
- chronic use of NSAIDs meaning those currently using NSAIDS daily for at least 3 months
- taking other homeopathic remedies during the perioperative period
- bleeding disorders as determined by self-disclosure or strong family history, patients in question who would like to participate in the study will have blood work obtained prior to operation
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- chronic medical conditions such as significant pulmonary, cardiac, liver, or kidney disease are excluded including poorly controlled hypertension or patients on more than one antihypertensive agent and patients with diabetes
- malignancy, infection, immunodeficiency, metabolic syndrome, infectious, or inflammatory gastrointestinal disease
- severe liver or kidney disease
- significant psychiatric disorders
- females who are breast feeding or pregnant
- history of nasal surgery
- history of head and neck malignancy
- taking oral corticosteroid therapy
- undergoing additional surgery other than primary rhinoplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Arnica Montana and Bromelain in Rhinoplasty
The purpose of this study is to assess the perioperative use of Arnica Montana and the combined use of Arnica Montana and Bromelain in aiding the body's wound healing functions during the postoperative period after rhinoplasty. The secondary objective of the study is to determine if there is a reduction in postoperative edema when Arnica Montana and Bromelain are combined. Another secondary objective is to demonstrate increased patient satisfaction with the use of Arnica Montana and the combination Arnica Montana and Bromelain.
- Conditions
- Wound Healing
- Being tested
- Arnica Montana, Bromelain, Placebo
- Keywords
- Rhinoplasty, Arnica Montana, Bromelain, Body healing post op, Rhinoplasty Outcome Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnica MontanaDietary supplement
Arnica Montana is from the Asteraceae plant family and is native to the mountain areas in Europe and western North America. It is reported to have anti-inflammatory, antiseptic, and vasodilatory properties and is often used in plastic surgery to help reduce pain, edema, and ecchymosis postoperatively.
BromelainDietary supplement
Bromelain is a protease enzyme derived from the pineapple plant, Ananas comosus, which has been used to reduce swelling, inflammation, and pain and may help to reduce wound healing time.
PlaceboOther
A pharmacologically inert preparation
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will take two placebo pills q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone. Receives: Other: Placebo |
| Arnica Montana | Experimental | Participants will take Arnica Montana, 30C oral, pill and a placebo pill q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone. Receives: Dietary Supplement: Arnica Montana; Other: Placebo |
| Arnica Montana and Bromelain | Experimental | Participants will take Bromelain, 500mg oral pill + Arnica Montana, 30C oral, q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone. Receives: Dietary Supplement: Arnica Montana; Dietary Supplement: Bromelain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecchymosis extent 7 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.
Measured: 7 days
Ecchymosis extent 14 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.
Measured: 14 days
Ecchymosis extent 28 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.
Measured: 28 days
Ecchymosis color density 7 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.
Measured: 7 days
Ecchymosis color density 14 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.
Measured: 14 days
Ecchymosis color density 28 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.
Measured: 28 days
Edema 7 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.
Measured: 7 days
Edema 14 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.
Measured: 14 days
Edema 28 days post rhinoplasty
Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.
Measured: 28 days
Secondary outcomes (1)
Change in patient satisfaction
Participants will complete the validated Rhinoplasty Outcome Evaluation (ROE) at their initial consultation visit (preoperative responses) which will be compared to their postoperative survey to assess overall patient satisfaction in regards to their rhinoplasty one month postoperatively. The ROE questionnaire has 6 questions, each with 5 answer options, graded from 0 to 4 so scores can range from 0 to 24. In order to make understanding easier, the score obtained must be divided by 24 and multiplied by 100, which leads to a score varying between zero and 100, and the higher the score, the greater is the patient's satisfaction with the nose surgery.
Measured: baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study startAug 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: The study could not be conducted since funding was not obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Wulu, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586232
- Sponsor's protocol ID
- H-37291
- Status last verified
- Aug 2019
- First submitted
- 3 Jul 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arnica Montana and Bromelain in Rhinoplasty
- ClinicalTrials.gov ID
- NCT03586232
- Acronym / sponsor ID
- H-37291
- Conditions
- Wound Healing
- Keywords
- Rhinoplasty, Arnica Montana, Bromelain, Body healing post op, Rhinoplasty Outcome Evaluation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study could not be conducted since funding was not obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 13 Jul 2018 (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.
The purpose of this study is to assess the perioperative use of Arnica Montana and the combined use of Arnica Montana and Bromelain in aiding the body's wound healing functions during the postoperative period after rhinoplasty. The secondary objective of the study is to determine if there is a reduction in postoperative edema when Arnica Montana and Bromelain are combined. Another secondary objective is to demonstrate increased patient satisfaction with the use of Arnica Montana and the combination Arnica Montana and Bromelain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboParticipants will take two placebo pills q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone. |
| Arnica Montana | Experimental | Dietary Supplement: Arnica Montana, Other: PlaceboParticipants will take Arnica Montana, 30C oral, pill and a placebo pill q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone. |
| Arnica Montana and Bromelain | Experimental | Dietary Supplement: Arnica Montana, Dietary Supplement: BromelainParticipants will take Bromelain, 500mg oral pill + Arnica Montana, 30C oral, q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -adults scheduled for outpatient primary rhinoplasty with osteotomies at Boston Medical Center
Key exclusion criteria (15 listed)
- oral or contact allergies to Arnica Montana or to derivatives from the Ananas comosus or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies or Bromelain as determined by self disclosure.
- allergies to pineapple as Bromelain is from pineapple extract
- currently taking antiplatelet medication or anticoagulation medications
- chronic use of NSAIDs meaning those currently using NSAIDS daily for at least 3 months
- taking other homeopathic remedies during the perioperative period
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 MontanaArnica Montana is from the Asteraceae plant family and is native to the mountain areas in Europe and western North America. It is reported to have anti-inflammatory, antiseptic, and vasodilatory properties and is often used in plastic surgery to help reduce pain, edema, and ecchymosis postoperatively. | Dietary supplement | Arnica Montana, Arnica Montana and Bromelain |
| BromelainBromelain is a protease enzyme derived from the pineapple plant, Ananas comosus, which has been used to reduce swelling, inflammation, and pain and may help to reduce wound healing time. | Dietary supplement | Arnica Montana and Bromelain |
| PlaceboA pharmacologically inert preparation | Other | Arnica Montana, Control |
Primary outcome
Ecchymosis extent 7 days post rhinoplasty
Time frame: 7 days
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.
Ecchymosis extent 14 days post rhinoplasty
Time frame: 14 days
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.
Ecchymosis extent 28 days post rhinoplasty
Time frame: 28 days
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.
Ecchymosis color density 7 days post rhinoplasty
Time frame: 7 days
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.
Ecchymosis color density 14 days post rhinoplasty
Time frame: 14 days
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.
Ecchymosis color density 28 days post rhinoplasty
Time frame: 28 days
Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.
Edema 7 days post rhinoplasty
Time frame: 7 days
Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.
Edema 14 days post rhinoplasty
Time frame: 14 days
Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.
Edema 28 days post rhinoplasty
Time frame: 28 days
Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.
1 secondary outcome
Change in patient satisfaction
Time frame: baseline, 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Jacqueline Wulu, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arnica Montana and Bromelain in people with Wound Healing, run by Boston Medical Center at 1 site in United States.
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 1 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 Aug 2019. 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 United States. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ecchymosis extent 7 days post rhinoplasty (time frame: 7 days). The study lists 9 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 15 Aug 2019.