A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
|ClinicalTrials.gov Identifier: NCT01686464|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : September 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bell's Palsy||Drug: prednisone and valacyclovir treatments Device: Magnetic and Oxygen Treatment||Not Applicable|
Between June 1998 and January 2005, a total of 3002 subjects with BP were evaluated, 882 patients fulfilled the inclusion criteria and entered the study.
Patients were randomly assigned to either the prednisone-valacyclovir group(group 1) or the magnetic-oxygen group(group 2) . Among the 882 patients completing the study,825 patients in group 1 received prednisone, given as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days. 57 patients in group 2 received magnetic-oxygen treatment:MOMC treatment was given as daily 20 min section for 10 days with 2~3 days of intermission between;Oxygen therapy was given simultaneously at a flow rate of 2~3.0 L / min for the same duration during all acupuncture sections.
Clinical evaluation for the severity of paralysis was performed immediately before and after the treatment using the facial nerve grading (FNG) scores of House and Brackmann system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||882 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A New Clinical Therapy for Bell's Palsy|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
U.S. FDA Resources
Experimental: Magnetic - Oxygen
Magnetic and Oxygen Treatment for Bell's Palsy
Device: Magnetic and Oxygen Treatment
MOMC treatment was given as daily 20 min section for 10 days with 2~3 days of intermission between. Oxygen therapy was given simultaneously at a flow rate of 2~3.0 L / min for the same duration during all acupuncture sections.
Active Comparator: prednisone - valacyclovir
prednisone and valacyclovir treatments for bell palsy
Drug: prednisone and valacyclovir treatments
patients were administered prednisone as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days.
Other Name: prednisone and valacyclovir
- House-Brackmann scale [ Time Frame: the 20th day of completion of the treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686464
|the 4th Military Medical University|
|Xi'an, Shanxi, China, 710000|
|Principal Investigator:||yan L wang, Ph .D||Wenzhou Medical University|
|Study Chair:||Ping Li, M.D.||The 4th military medical university|