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Laser Acupuncture for Meniere Disease

NCT06544434 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

  • Meniere Disease

Interventions

DEVICE

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.

DRUG

Betahistine Mesylate tablet

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

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2024-09-30
Completion
2024-10-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544434 on ClinicalTrials.gov