Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
324 participants
INTERVENTIONAL
2021-05-01
2024-10-20
Brief Summary
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Methods: We enrolled 324 patients at Beijing Tongren Hospital. Patients completed outcome measures at baseline, 3 months, 6 months, and 12 months. Video head impulse test (vHIT), The Caloric Test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry (PTA), and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Laser acupuncture 3 month Group
Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)
MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg, 3 times a day.
Sham acupuncture Group
Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)
MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg, 3 times a day.
Control Group
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg, 3 times a day.
Interventions
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Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)
MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
Betahistine Mesylate tablet
Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg, 3 times a day.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Planning for pregnancy, those in pregnancy, or those who were lactating.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Locations
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Beijing TongRen Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAMD-RCT-2024
Identifier Type: -
Identifier Source: org_study_id
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