Arnica Montana and Bromelain in Rhinoplasty
关键词
抽象
日期
| 最后验证: | 07/31/2019 |
| 首次提交: | 07/02/2018 |
| 提交的预估入学人数: | 07/02/2018 |
| 首次发布: | 07/12/2018 |
| 上次提交的更新: | 08/12/2019 |
| 最近更新发布: | 08/14/2019 |
| 实际学习开始日期: | 07/31/2019 |
| 预计主要完成日期: | 07/31/2020 |
| 预计完成日期: | 07/31/2020 |
状况或疾病
干预/治疗
Dietary Supplement: Arnica Montana
Dietary Supplement: Arnica Montana and Bromelain
Other: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: 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. | |
| Experimental: 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. | |
| Experimental: 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. | Dietary Supplement: Arnica Montana and Bromelain 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Ecchymosis extent 7 days post rhinoplasty [7 days]
2. Ecchymosis extent 14 days post rhinoplasty [14 days]
3. Ecchymosis extent 28 days post rhinoplasty [28 days]
4. Ecchymosis color density 7 days post rhinoplasty [7 days]
5. Ecchymosis color density 14 days post rhinoplasty [14 days]
6. Ecchymosis color density 28 days post rhinoplasty [28 days]
7. Edema 7 days post rhinoplasty [7 days]
8. Edema 14 days post rhinoplasty [14 days]
9. Edema 28 days post rhinoplasty [28 days]
次要成果指标
1. Change in patient satisfaction [baseline, 28 days]
