Arnica Montana and Bromelain in Rhinoplasty
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 07/31/2019 |
| Pirmasis pateikimas: | 07/02/2018 |
| Numatytas registravimas pateiktas: | 07/02/2018 |
| Pirmas paskelbtas: | 07/12/2018 |
| Paskutinis atnaujinimas pateiktas: | 08/12/2019 |
| Paskutinis atnaujinimas paskelbtas: | 08/14/2019 |
| Faktinė studijų pradžios data: | 07/31/2019 |
| Numatoma pirminio užbaigimo data: | 07/31/2020 |
| Numatoma studijų užbaigimo data: | 07/31/2020 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: Arnica Montana
Dietary Supplement: Arnica Montana and Bromelain
Other: Placebo
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
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]
Antrinės rezultatų priemonės
1. Change in patient satisfaction [baseline, 28 days]
