The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Olfactory Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Chinese Medicine with 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

Group Type EXPERIMENTAL

Traditional Chinese Medicine CU Xiu Tang

Intervention Type 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

Olfactory Training

Intervention Type OTHER

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

repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months

Group Type EXPERIMENTAL

Olfactory Training

Intervention Type OTHER

repeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months

Interventions

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Traditional Chinese Medicine CU Xiu Tang

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

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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Olfactory Training

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No