Effects of Arnica Montana and Bromelain in Rhinoplasty
| Registry | NCT03586232 |
|---|---|
| Status | Withdrawn - The study could not be conducted since funding was not obtained. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, supportive care |
| Sponsor | Boston Medical Center (Other) |
| Conditions | Wound Healing |
| Interventions | Arnica Montana, Bromelain, Placebo (Dietary supplement, other) |
| Dates | start 2019-08-01 (estimated), primary completion 2020-08-01 (estimated), completion 2020-08-01 (estimated), first posted 2018-07-13, last updated 2019-08-15 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Wound Healing All trials of Arnica Montana All trials of Bromelain
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | Placebo comparator | Other: Placebo | Participants 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: Placebo | 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. |
| Arnica Montana and Bromelain | Experimental | Dietary Supplement: Arnica Montana; Dietary Supplement: Bromelain | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: -adults scheduled for outpatient primary rhinoplasty with osteotomies at Boston Medical Center Exclusion Criteria: * 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 * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Boston Medical Center | Boston, Massachusetts | United States |