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Not yet recruitingNCT07334002Updated Mar 23, 2026

The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

An interventional study of Neural Therapy of Huneke and Betahistine 24 mg bid (Betaserc) in Tinnitus and Neural Therapy of Huneke, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus.

The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.

Read the detailed description

All patients with normal otologic examinations and a type A tympanogram will be included in the study. Those who meet the exclusion criteria will not be included in the study, and patients will be randomized. Subsequently, the groups will be divided into two groups: those who will receive only medical treatment and those who will receive neural therapy in addition to medical treatment. Patients will be administered tinnitus severity questionnaires based on the SF-12 (short form) and the VAS (visual analog scale), the Turkish adaptation of the Tinnitus Disability Inventory (THI). The same questionnaires will be administered at their follow-up visits three months later.

02

Conditions studied

  • Tinnitus
  • Neural Therapy of Huneke

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Keywords

  • Neural Therapy of Huneke
  • Tinnitus
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In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 114 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a type A tympanogram in the tympanogram of all cases with normal otological examinations (air-bone gap should not be observed in any case).

Exclusion criteria

Exclusion Criteria:

  • Patients with a disease that may cause objective tinnitus,

    • Otosclerosis,
    • Chronic otitis media,
    • Acoustic tumor,
    • Meniere's disease,
    • History of ear surgery or head trauma, and those with neuropsychiatric diseases.

Also:

  • Patients who have had ear surgery,
  • Permanent hearing loss (total),
  • Severe cardiovascular system failure, uncontrolled arrhythmia,
  • Severe renal failure, or liver failure
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Procedure: Neural Therapy of Huneke

  • Active comparator
    Control Group

    Drug: Betahistine 24 mg bid (Betaserc)

Interventions

  • ProcedureNeural Therapy of Huneke

    The aim for tinnitus and facial pain is to regulate the trigeminal system and autonomic balance. Concentration used: Lidocaine 0.5%. The auriculotemporal, infraorbital, zygomaticotemporal, and stellate regions were targeted. Puncture applications: 0.3-0.5 mL will be administered behind the ear, around the mastoid process, behind the tragus, and in the temporomandibular region. If necessary, the stellate ganglion area can be supplemented with regulation injections. Negative aspiration and aseptic technique will be applied before each application. Transient mild dizziness or local redness may occur after application. To avoid the risk of systemic toxicity, the total dose should generally not exceed a maximum of 200 mg of lidocaine.

  • Patients will be given Betahistine 16-48 mg/day in divided doses, depending on their weight and disease severity.

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What researchers measure

Primary outcomes

  1. Turkish version of the Tinnitus Disability Questionnaire (THI)

    Time frame: 3 months

  2. SF-12 (short form)

    Time frame: 3 months

  3. Tinnitus severity according to VAS (visual analog scale)

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: 6 months

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07334002
Responsible party
Roza Jizel Dagdelen MD (Medical Doctor , Assistant Researcher, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Jan 12, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
May 15, 2026 (estimated)
Completion
May 26, 2026 (estimated)
Last update
Mar 23, 2026

Study contacts

Roza Jizel Dağdelen, MD
Contact
rozadagdelen@gmail.com
+90 212 373 50 00
Jülide Öncü Alptekin, Professor Doctor, MD
Contact
julideoncu@yahoo.com
+90507 231 6817

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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