The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Olfactory Disorder

Treatments: Drug: Traditional Chinese Medicine CU Xiu Tang; Other: Olfactory Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05448898

ODCT2002-6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

278 participants in 2 patient groups

Traditional Chinese Medicine with olfactory training

Experimental group

Description:

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

Treatment:

Other: Olfactory Training

Drug: Traditional Chinese Medicine CU Xiu Tang

Olfactory training

Experimental group

Description:

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

Treatment:

Other: Olfactory Training