RecruitingPhase 2NCT06544434

Laser Acupuncture for Meniere Disease

Laser Acupuncture for Meniere Disease: A Randomized Controlled Trial


Sponsor

Beijing Tongren Hospital

Enrollment

324 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Objective: To evaluate the effect of laser acupuncture for the patients Meniere disease. 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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Betahistine Mesylate tablet and a medical device called Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy) for people with meniere disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMultiwave 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.

DRUGBetahistine Mesylate tablet

Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg, 3 times a day.


Locations(1)

Beijing TongRen Hospital, Capital Medical University

Beijing, China

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NCT06544434


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