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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Chinese Medicine with olfactory training | Experimental | Traditional Chinese Medicine therapy: Oral Traditional Chinese Medicine CU Xiu Tang once a day for at least 3 months Olfactory training: repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months |
|
| Olfactory training | Experimental | repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicine CU Xiu Tang | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Olfactory 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of Olfactory Disorders | every patients should answer the Questionnaire of Olfactory Disorders and record the results. The answers should be agreed, Partially agreed and disagreed. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongmeng Yu, Dr | Contact | 13501730576 | hongmengyush@163.com | |
| Qi Dai, Dr | Contact | 18717835116 | 263395115@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmeng Yu, Dr | Eye & ENT Hospital, Fudan University | Principal Investigator |
| YanQing Li, Dr | Eye & ENT Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Olfactory Training | Other | repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 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. |
| 3 months |