The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Olfactory Disorder
• Intervention / Treatment: Drug: Traditional Chinese Medicine CU Xiu Tang; Other: Olfactory Training

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 Type: Interventional
• Enrollment (Anticipated): 278
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongmeng Yu, Dr; Phone Number: 13501730576; Email: hongmengyush@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Eye & ENT Hospital
      • Contact: Hongmeng Yu, Dr; Phone Number: 13501730576; Email: hongmengyush@fudan.edu.cn
      • Principal Investigator: YanQing Li, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: YanQing Li, Dr, Eye & ENT Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Olfactory Function
• Other Study ID Numbers: ODCT2002-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No