Effects of Arnica Montana and Bromelain in Rhinoplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Ecchymosis color density 7 days post rhinoplasty
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults scheduled for outpatient primary rhinoplasty with osteotomies at Boston Medical Center
排除标准
- •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
研究组 & 干预措施
Arnica Montana
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.
干预措施: Arnica Montana (Dietary Supplement)
Control
Participants will take two placebo pills q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone.
干预措施: Placebo (Other)
Arnica Montana
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.
干预措施: Placebo (Other)
Arnica Montana and 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.
干预措施: Bromelain (Dietary Supplement)
Arnica Montana and 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.
干预措施: Arnica Montana (Dietary Supplement)
结局指标
主要结局
Ecchymosis color density 7 days post rhinoplasty
时间窗: 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.
Edema 14 days post rhinoplasty
时间窗: 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.
Ecchymosis extent 7 days post rhinoplasty
时间窗: 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 color density 14 days post rhinoplasty
时间窗: 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.
Edema 28 days post rhinoplasty
时间窗: 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.
Ecchymosis extent 14 days post rhinoplasty
时间窗: 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
时间窗: 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 28 days post rhinoplasty
时间窗: 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
时间窗: 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.
次要结局
- Change in patient satisfaction(baseline, 28 days)