The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

Olfactory Disorder Clinical Trial

Official title:

The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448898
• Other study ID #: ODCT2002-6
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: Hongmeng Yu, Dr
• Phone: 13501730576
• Email: hongmengyush[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Olfactory Disorder

Intervention

Drug:
• 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

Other:
• 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

Locations

Country	Name	City	State
China	Eye & ENT Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	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