Arnica Montana and Bromelain in Rhinoplasty

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Wound Healing

Treatments: Other: Placebo; Dietary Supplement: Bromelain; Dietary Supplement: Arnica Montana

Study type: Interventional

Funder types: Other

Identifiers

NCT03586232

H-37291

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Participants will take two placebo pills q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone.

Treatment:

Other: Placebo

Arnica Montana

Experimental group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Arnica Montana

Arnica Montana and Bromelain

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Arnica Montana

Dietary Supplement: Bromelain