EFFECTIVENESS OF OLFACTORY TRAINING AND ALPHALIPOIC ACID IN THE TREATMENT OF SEVERE OLFACTORY DYSFUNCTION- A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Olfaction test scores (Threshold score,
研究概览
简要总结
Olfactory loss has been shown to have a negative impact in the quality of life, by preventing the detection of hazardous smells like smoke, gas leaks and chemicals. It also prevents the patients from enjoying food thereby resulting in weight loss or gain and psychological distress. The inability to percieve smell is termed as anosmia while the reduced perception to smell is hyposmia. The treatment options for smell loss are limited. However, regular structured exposure to odors through olfactory training has been found to be effective by stimulation of the olfactory neuroepithelium, although the exact mechanism is unknown. Likewise, alpha lipoic acid with their antioxidant effect has also been found to improve the sense of smell in olfactory loss patients. This study aims to compare the efficacy of olfactory training and alpha lipoic acid in the improvement of smell in post viral and idiopathic olfactory loss patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 16 years of age History of loss of smell Severe hyposmia or anosmia on evaluation No identifiable cause.
排除标准
- •Patients below 16 years of age Pregnancy Etiology of smell loss other than post infectious or idiopathic Prior sinus, skull base or brain surgery Cognitive or psychiatric dysfunction Head injury Patients having nasal mass.
结局指标
主要结局
Change in Olfaction test scores (Threshold score,
时间窗: At the end of 3 months
identification score and composite score) post treatment
时间窗: At the end of 3 months
次要结局
- Change in Visual Analogue Score and Self Administered Odor Questionaire scores post treatment(two and a half years)