Trial Outcomes & Findings for Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain (NCT NCT03944629)
NCT ID: NCT03944629
Last Updated: 2026-01-29
Results Overview
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
Recruitment status
COMPLETED
Target enrollment
53 participants
Primary outcome timeframe
Day 3 and Day 5
Results posted on
2026-01-29
Participant Flow
Participant milestones
| Measure |
Study Group
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Study Group
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain
Baseline characteristics by cohort
| Measure |
Study Group
n=27 Participants
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
n=26 Participants
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
53 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
22.4 years
n=41 Participants
|
23.5 years
n=1581 Participants
|
22.95 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=41 Participants
|
13 Participants
n=1581 Participants
|
28 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=41 Participants
|
13 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Multi
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=41 Participants
|
26 participants
n=1581 Participants
|
53 participants
n=4626 Participants
|
|
BASELINE Postoperative Swelling
Right Side
|
40.6264 Cm^2
STANDARD_DEVIATION 23.21150 • n=41 Participants
|
45.9915 Cm^2
STANDARD_DEVIATION 27.64742 • n=1581 Participants
|
43.30895 Cm^2
STANDARD_DEVIATION 2.68255 • n=4626 Participants
|
|
BASELINE Postoperative Swelling
Left Side
|
40.589 Cm^2
STANDARD_DEVIATION 23.28939 • n=41 Participants
|
45.0376 Cm^2
STANDARD_DEVIATION 23.79449 • n=1581 Participants
|
42.8133 Cm^2
STANDARD_DEVIATION 2.2243 • n=4626 Participants
|
|
BASELINE PAIN
|
0.4259 units on a scale
STANDARD_DEVIATION 1.53788 • n=41 Participants
|
0.2712 units on a scale
STANDARD_DEVIATION 0.80302 • n=1581 Participants
|
0.34855 units on a scale
STANDARD_DEVIATION 0.07735 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 3Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
Outcome measures
| Measure |
Study Group
n=27 Participants
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
n=26 Participants
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Change in Postoperative Facial Swelling From Baseline to Day 3
Left Side
|
7.4336 cm^2
Standard Deviation 9.57758
|
7.0346 cm^2
Standard Deviation 12.41098
|
|
Change in Postoperative Facial Swelling From Baseline to Day 3
Right Side
|
9.2508 cm^2
Standard Deviation 10.29876
|
9.3320 cm^2
Standard Deviation 13.95499
|
PRIMARY outcome
Timeframe: Day 3 and Day 5Population: three subjects did not complete the day 5 visit and thus, data was only analyzed for 50 subjects instead of 53.
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
Outcome measures
| Measure |
Study Group
n=26 Participants
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
n=24 Participants
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Change in Postoperative Facial Swelling From Day 3 to Day 5
Left Side
|
-3.225 cm^2
Standard Deviation 8.90529
|
-2.6692 cm^2
Standard Deviation 10.96405
|
|
Change in Postoperative Facial Swelling From Day 3 to Day 5
Right Side
|
-1.9433 cm^2
Standard Deviation 8.22751
|
-1.7292 cm^2
Standard Deviation 9.08343
|
PRIMARY outcome
Timeframe: Baseline and Day 5Population: three subjects did not complete the day 5 visit and thus, data was only analyzed for 50 subjects instead of 53.
Primary outcome is the change in postoperative facial swelling volume as measured by the 3dMD™ system
Outcome measures
| Measure |
Study Group
n=26 Participants
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
n=24 Participants
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Change in Postoperative Facial Swelling From Baseline to Day 5
Right Side
|
7.6311 cm^2
Standard Deviation 7.76589
|
5.7718 cm^2
Standard Deviation 12.17906
|
|
Change in Postoperative Facial Swelling From Baseline to Day 5
Left Side
|
4.4662 cm^2
Standard Deviation 10.41910
|
2.7803 cm^2
Standard Deviation 12.07358
|
SECONDARY outcome
Timeframe: Baseline and Day 3Change in postoperative pain as measured by 0-100 mm Visual Analog Scale, from baseline to post-operative Day 3, and from baseline to post-operative Day 5 (0 being the least pain, 100 being the most pain)
Outcome measures
| Measure |
Study Group
n=27 Participants
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
n=26 Participants
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Change in Post Operative Pain From Baseline to Day 3
|
1.741 score on a scale
Standard Deviation 1.889
|
2.248 score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline and Day 5Population: three subjects did not complete the day 5 visit and thus, data was only analyzed for 50 subjects instead of 53.
Change in postoperative pain as measured by 0-100 mm Visual Analog Scale, from baseline to post-operative Day 3, and from baseline to post-operative Day 5 (0 being the least pain, 100 being the most pain)
Outcome measures
| Measure |
Study Group
n=26 Participants
The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
SinEcch: The study group will be comprised of subjects who will receive homeopathic Arnica montana (SinEcch™) for perioperative management of edema and pain.
|
Control Group
n=24 Participants
The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
Placebo: The control group will be comprised of subjects who will receive matching SinEcch™ placebo (sugar pill).
|
|---|---|---|
|
Change in Post Operative Pain From Baseline to Day 5
|
0.523 score on a scale
Standard Deviation 1.186
|
0.935 score on a scale
Standard Deviation 1.077
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigatort
Tufts University School of Dental Medicine
Phone: (617) 636-6515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60