The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

Not Applicable

• Conditions: Olfactory Disorder
• Interventions: Drug: Traditional Chinese Medicine CU Xiu Tang; Other: Olfactory Training

• Registration Number: NCT05448898
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-07
• Study First Posted: 2022-07-08
• Last Update Posted: 2022-07-11
• Study Start: 2022-07-15
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 278

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine with olfactory training	Olfactory Training	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	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
Traditional Chinese Medicine with olfactory training	Traditional Chinese Medicine CU Xiu Tang	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

Primary Outcome Measures

Name	Time	Method
Olfactory function test result	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Odor threshold (T), Odor Discrimination (D), Odor Identification (I)	3 months	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.
the Visual Analogue Scale(VAS) of Olfactory Function	3 months	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.

Trial Locations

Locations (1)

Eye & ENT Hospital; 🇨🇳 Shanghai, Shanghai, China