Olfactory DisorderNCT05448898
The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction
A study testing Traditional Chinese Medicine CU Xiu Tang and Olfactory Training in people with Olfactory Disorder, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Olfactory Disorder
- What is being tested?
- Traditional Chinese Medicine CU Xiu Tang and Olfactory Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Olfactory dysfunction;
- 18 ≤ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital
Shanghai, Shanghai Municipality, 200031
hongmeng Yu, Dr, 13501730576, hongmengyush@fudan.edu.cn
Qi Dai, Dr, 18717835116, 263395115@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Olfactory Disorder
- Being tested
- Traditional Chinese Medicine CU Xiu Tang, Olfactory Training
- Keywords
- Olfactory Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine CU Xiu TangDrug
Also called Olfactory Training
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Traditional Chinese Medicine CU Xiu Tang; Other: 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 Receives: Other: Olfactory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DisorderStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongmeng Yu, Dr, Principal investigator, Eye & ENT Hospital, Fudan UniversityYanQing Li, Dr, Principal investigator, Eye & ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448898
- Sponsor's protocol ID
- ODCT2002-6
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05448898
- Acronym / sponsor ID
- ODCT2002-6
- Conditions
- Olfactory Disorder
- Keywords
- Olfactory Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine with olfactory training | Experimental | Drug: Traditional Chinese Medicine CU Xiu Tang, Other: Olfactory TrainingTraditional 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 |
| Olfactory training | Experimental | Other: Olfactory Trainingrepeat and deliberate sniffing of a set of odorants for 20 seconds each at least twice a day for at least 3 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Olfactory dysfunction;
- 18 ≤ 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine CU Xiu TangAlso: Olfactory TrainingOral 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 | Drug | Traditional Chinese Medicine with olfactory training |
| Olfactory Trainingrepeat 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, Traditional Chinese Medicine with olfactory training |
Primary outcome
Olfactory function test result
Time frame: 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.
2 secondary outcomes
Odor threshold (T), Odor Discrimination (D), Odor Identification (I)
Time frame: 3 months
the Visual Analogue Scale(VAS) of Olfactory Function
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongmeng Yu, Dr principal investigator
Eye & ENT Hospital, Fudan University
YanQing Li, Dr principal investigator
Eye & ENT Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine CU Xiu Tang and Olfactory Training in people with Olfactory Disorder, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongmeng Yu, Dr (13501730576, hongmengyush@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory function test result (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.