NCT05448898

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

July 4, 2022

Last Update Submit

July 7, 2022

Conditions

Olfactory Disorder

Keywords

Olfactory Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Odor threshold (T), Odor Discrimination (D), Odor Identification (I)

    3 months

  • the Visual Analogue Scale(VAS) of Olfactory Function

    3 months

Other Outcomes (1)

  • Questionnaire of Olfactory Disorders

    3 months

Study Arms (2)

Traditional Chinese Medicine with olfactory training

EXPERIMENTAL

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 TangOther: Olfactory Training

Olfactory training

EXPERIMENTAL

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

Interventions

Traditional Chinese Medicine CU Xiu TangDRUG

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

Also known as: Olfactory Training
Traditional Chinese Medicine with olfactory training
Olfactory TrainingOTHER

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

Olfactory trainingTraditional Chinese Medicine with olfactory training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Olfactory dysfunction;
  • ≤ age ≤ 55 years old;
  • No active infection, such as uncontrolled pneumonia;
  • Women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods.

You may not qualify if:

  • Refuse to sign informed consent;
  • With other diseases that affect the result, such as severe hepatic and renal dysfunction and the investigators believes will interfere with the treatment;
  • Pregnant or lactating women;
  • Without personal freedom and independent civil capacity;
  • Enrolled in other intervention clinical trials;
  • Autoimmune diseases;
  • Other situations that the investigators think are not suitable for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye & ENT Hospital

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

Olfactory Training

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Hongmeng Yu, Dr

    Eye & ENT Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

  • YanQing Li, Dr

    Eye & ENT Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongmeng Yu, Dr

CONTACT

13501730576hongmengyush@163.com

Qi Dai, Dr

CONTACT

18717835116263395115@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 8, 2022

Study Start

July 15, 2022

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations

CN(1)