Recruiting NCT07702149
Diet Restiction in Subjects With Behcet Disease and Complaint of Tinnitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: diet restriction.
- Who it may be relevant to
- Registry conditions: Behcet Disease, Obesity, Subjective Tinnitus. Basic parameters: 40 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
otogic problems are varied in bechet disorder, tinnnitus is one of these problems. obesity may increase this probelm
Detailed description
Forty subjects with behcet disorder, excess weight, complaint o tinnnitus will divided to group I or group II. low caorie diet 12-week regeim wil be followed by 20-patient group I . the 20-patient group II will be waitlist.
Interventions
- Behavioral diet restriction
twenty subjects with behcet disorder, excess weight, complaint o tinnnitus will follow low calorie diet 12-week regeim.
Primary outcome measures
- tinnitus handicap inventory [Time frame: it will be measured after 12 weeks]
Secondary outcome measures (10)
- visual analog scale of severity of complint of tinnitus [Time frame: It will be measured after 12 weeks]
- visual analog scale of discomfort induced by complint of tinnitus [Time frame: It will be measured after 12 weeks]
- tinnitus reaction scale [Time frame: It will be measured after 12 weeks]
- waist circumfereence [Time frame: it will be measured after 12 weeks]
- body mass index [Time frame: It will be measured after 12 weeks]
- sate trait anxiety inventory [Time frame: It will be measured after 12 weeks]
- beck depression scale [Time frame: It will be measured after 12 weeks]
- satifiaction with life scale [Time frame: It will be measured after 12 weeks]
- behcet diseae life quality scale [Time frame: It will be measured after 12 weeks]
- insomnia severity index [Time frame: It will be measured after 12 weeks]
Eligibility criteria
Inclusion criteria
- behcet disease
- obesity
- subjective tinnitus (bilateral)
Exclusion criteria
- other autoimune diseases
- refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Cairo University — Giza
- Cairo University — Dokki
Identifiers
NCT: NCT07702149 · IRB00014233-87