Clinical trial NCT05448898: The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction
Official title: The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Olfactory Disorder
Keywords: Olfactory Function
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies have demonstrated that patients with olfactory dysfunction could improve the olfactory function after olfactory training. But the efficacy of Traditional Chinese Medicine is unknown.The purpose of this study is to evaluate its efficacy in olfactory dysfunction.

Detailed description: A recent meta-analysis found significant positive effects of olfactory training on the individual subcomponents of odor threshold, discrimination, identification, and the composite TDI score. In addition to the evidenced improvement in olfactory function after olfactory training, this form of treatment carries very little risk of adverse effects, is cheap, and can be administered by the patient. For these collective reasons, olfactory training is an attractive treatment modality. Chinese experts consensus on diagnosis and treatment of olfactory dysfunction in 2017 shown that some evidences proved that Traditional Chinese Medicine treatment would benefit olfactory dysfunction but the evidences is not adequate. Until now, the efficacy of Traditional Chinese Medicine is controversial. This study investigate the efficacy and the safety of Traditional Chinese Medicine and olfactory training as a treatment for patients with olfactory dysfunction.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Olfactory dysfunction;
2. 18 ≤ age ≤ 55 years old;
3. No active infection, such as uncontrolled pneumonia;
4. Women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods.

Exclusion Criteria:

1. Refuse to sign informed consent;
2. With other diseases that affect the result, such as severe hepatic and renal dysfunction and the investigators believes will interfere with the treatment;
3. Pregnant or lactating women;
4. Without personal freedom and independent civil capacity;
5. Enrolled in other intervention clinical trials;
6. Autoimmune diseases;
7. Other situations that the investigators think are not suitable for the trial.

Primary outcomes:
measure: Olfactory function test result
timeFrame: 3 months
Secondary outcomes:
measure: Odor threshold (T), Odor Discrimination (D), Odor Identification (I)
timeFrame: 3 months
measure: the Visual Analogue Scale(VAS) of Olfactory Function
timeFrame: 3 months
Other outcomes:
measure: Questionnaire of Olfactory Disorders
timeFrame: 3 months
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital, Fudan University
name: Hongmeng Yu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye & ENT Hospital, Fudan University
name: YanQing Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: