The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

• Sponsor: Eye & ENT Hospital of Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05448898
• Collaborator: (none)
• Enrollment: 278
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.5
• Patients Per Site Per Month: 15.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Olfactory Disorder	Drug: Traditional Chinese Medicine CU Xiu Tang; Other: Olfactory Training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction: A Randomized Controlled Trial
• Anticipated Study Start Date: Jul 15, 2022
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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 Names: Olfactory Training ; 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
Experimental: 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	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Other Outcome Measures

1. Questionnaire of Olfactory Disorders [3 months]

   every patients should answer the Questionnaire of Olfactory Disorders and record the results. The answers should be agreed, Partially agreed and disagreed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye & ENT Hospital	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

• Eye & ENT Hospital of Fudan University

Investigators

• Principal Investigator: Hongmeng Yu, Dr, Eye & ENT Hospital, Fudan University
• Principal Investigator: YanQing Li, Dr, Eye & ENT Hospital, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eye & ENT Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT05448898
• Other Study ID Numbers: ODCT2002-6
• First Posted: Jul 8, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eye & ENT Hospital of Fudan University: Olfactory Function

Study Results

No Results Posted as of Jul 11, 2022