Trial Outcomes & Findings for Acupuncture for Nasal Congestion in Allergic Rhinitis (NCT NCT05709977)
NCT ID: NCT05709977
Last Updated: 2026-03-13
Results Overview
To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after 6 weeks of treatments based on VAS score. VAS, 0 = no nasal congestion, and 10 = most severe nasal congestion.
COMPLETED
NA
11 participants
After 6 weeks (visit 8).
2026-03-13
Participant Flow
The first participant was enrolled on April 20, 2023. Between April and September 2023, a total of 10 eligible participants were recruited. Recruitment efforts involved distributing promotional materials via e-mail and postal mail to 200 physicians in the vicinity of Mermaid Medicine®.
11 participants were enrolled; however, 1 participant was found to be ineligible. Therefore, a total of 10 eligible participants were enrolled.
Participant milestones
| Measure |
Acupuncture Arm
Fixed set of acupuncture points
Acupuncture: Fixed set of acupuncture points
|
Control (Carelastin®) Arm
Carelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day)
Antihistamine nasal spray: Carelastin® (1 mg/ml) azelastine nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acupuncture Arm
n=4 Participants
Fixed set of acupuncture points
Acupuncture: Fixed set of acupuncture points
|
Control (Carelastin®) Arm
n=6 Participants
Carelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day)
Antihistamine nasal spray: Carelastin® (1 mg/ml) azelastine nasal spray
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.25 years
n=4 Participants
|
48.50 years
n=6 Participants
|
44 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: After 6 weeks (visit 8).Population: One subject withdrew before treatment protocol started.
To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after 6 weeks of treatments based on VAS score. VAS, 0 = no nasal congestion, and 10 = most severe nasal congestion.
Outcome measures
| Measure |
Acupuncture Arm
n=4 Participants
Fixed set of acupuncture points
Acupuncture: Fixed set of acupuncture points
|
Control (Carelastin®) Arm
n=6 Participants
Carelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day)
Antihistamine nasal spray: Carelastin® (1 mg/ml) azelastine nasal spray
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) From Baseline to 6 Weeks (6-week Value Compared to Baseline Value)
|
-8 Scale points
Interval -8.0 to -6.0
|
-2 Scale points
Interval -5.0 to 0.0
|
Adverse Events
Acupuncture Arm
Control (Carelastin®) Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place