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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
278
Oral Traditional Chinese Medicine CU Xiu Tang once a day and repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months
repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months
Eye & ENT Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOlfactory function test result
Olfactory tests combination of odor threshold (T), odor discrimination (D), and odor identification (I). The minimum values is 0, the maximum values of odor threshold (T), discrimination (D), and identification (I) is 16, the sum of the scores is TDI, which is between 0 to 48, the higher scores mean a better outcome.
Time frame: 3 months
Odor threshold (T), Odor Discrimination (D), Odor Identification (I)
The scale of odor threshold (T), discrimination (D), and identification (I).The minimum values is 0, the maximum values of odor threshold (T), discrimination (D), and identification (I) is 16, the higher scores mean a better outcome.
Time frame: 3 months
the Visual Analogue Scale(VAS) of Olfactory Function
Participants should value their olfactory function by use the Visual Analogue Scale#VAS), the minimum values is 0, the maximum values is 10, the higher scores mean a better outcome.
Time frame: 3 months
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