Traumatic AnosmiaNCT05199623
The Effect of Chinese Herbal Medicine as an Adjuvant Therapy in the Treatment of Traumatic Anosmia
A study testing tailored Guizhi decoction and Olfactory training (OT) in people with Traumatic Anosmia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Objective: To investigate the effect of Chinese herbal medicine (CHM) as an adjuvant therapy in the treatment of traumatic anosmia. Methods: Patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (PEA) odor detection threshold remained -1 after treatment with steroid, zinc… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Traumatic Anosmia
- What is being tested?
- tailored Guizhi decoction and Olfactory training (OT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2018to 9 Jul 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a clear history of loss of smell after an episode of head injury
- PEA threshold was -1, which is assumed to be anosmic
Who cannot join
- One month later, they received birhinal and unirhinal PEA threshold tests. Any patient whose birhinal or unirhinal threshold was below -1 was excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chinese Herbal Medicine(Tailored Guizhi Decoction) as an Adjuvant Therapy in the Treatment of Traumatic Anosmia
Objective: To investigate the effect of Chinese herbal medicine (CHM) as an adjuvant therapy in the treatment of traumatic anosmia.
Methods: Patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (PEA) odor detection threshold remained -1 after treatment with steroid, zinc, and olfactory training (OT) for one month, were included in this study between September of 2018 and November of 2020. They were randomly divided into 2 groups, with patients in the CHM group taking CHM (tailored Guizhi decoction) and performing OT, and those in the OT group receiving OT only for 6 months. After 3 months' and 6 months' treatment, the olfactory function was evaluated by both the PEA threshold test and the traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC). Magnetic resonance imaging was performed to measure the volume of olfactory bulbs after 6 months' treatment.
- Conditions
- Traumatic Anosmia
- Being tested
- tailored Guizhi decoction, Olfactory training (OT)
- Keywords
- Chinese herbal medicine, Guizhi decoction, Olfactory training, Phenyl ethyl alcohol threshold test, Traumatic anosmia, University of Pennsylvania Smell Identification Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored Guizhi decoctionDrug
Tailored guizhi decoction powder is a compound Chinese herbal medicine which contains 7.0g of guizhi, 1.5g of chuanxiong, 1.5g of zhimu, 1.5g of xinyi, 0.3g of mahuang, 1.0g of baizh, 2.0g of jili, 1.5g of fuling, and 1.0g of danshen.
Olfactory training (OT)Behavioural
Four odorant bottles of PEA, lemon, eucalyptus, and clove oils were given. Patients were instructed to sniff the liquid in each bottle for 10 seconds, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| CHM(Chinese herbal medicine) group | Experimental | Treatment with steroid, zinc, and olfactory training for one month. And then, take CHM(Chinese herbal medicine) (tailored Guizhi decoction) and perform OT(olfactory training) for 6 months Receives: Drug: tailored Guizhi decoction; Behavioral: Olfactory training (OT) |
| OT(olfactory training) group | Active comparator | Treatment with steroid, zinc, and olfactory training for one month. And then, perform OT(olfactory training) only for 6 months. Receives: Behavioral: Olfactory training (OT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory test - Birhinal PEA threshold (3 months after treatment)
The PEA threshold test consists of different concentrations of a rose-like PEA odorant to measure the odor threshold. A 2-alternative forced-choice single-staircase procedure is used in the PEA test.
Measured: Change between before treatment and 3 months after treatment
Olfactory test - Birhinal PEA threshold (6 months after treatment)
The PEA threshold test consists of different concentrations of a rose-like PEA odorant to measure the odor threshold. A 2-alternative forced-choice single-staircase procedure is used in the PEA test.
Measured: Change between before treatment and 6 months after treatment
Olfactory test - UPSIT-TC (3 months after treatment)
UPSIT-TC is an odor identification test that is modified from the North American version of University of Pennsylvania Smell Identification Test(UPSIT). In the UPSIT-TC, 8 Odorants have been replaced to reflect the culture of the test-takers [20]. The UPSIT-TC is
composed of 40 tests. In each test, an odorant is embedded in microcapsules and positioned on the brown bottom strips of the test page. The patient scratches the strip with a pencil tip to release the odorant. Then he or she sniffs the released odorant and chooses from a set of 4 odor descriptors to identify the odorant. The test is scored as the number of odors identified correctly
Measured: Change between before treatment and 3 months after treatment
Olfactory test - UPSIT-TC (6 months after treatment)
UPSIT-TC is an odor identification test that is modified from the North American version of University of Pennsylvania Smell Identification Test(UPSIT). In the UPSIT-TC, 8 Odorants have been replaced to reflect the culture of the test-takers [20]. The UPSIT-TC is
composed of 40 tests. In each test, an odorant is embedded in microcapsules and positioned on the brown bottom strips of the test page. The patient scratches the strip with a pencil tip to release the odorant. Then he or she sniffs the released odorant and chooses from a set of 4 odor descriptors to identify the odorant. The test is scored as the number of odors identified correctly
Measured: Change between before treatment and 6 months after treatment
The volume of olfactory bulbs
MRI was performed to measure the volume of olfactory bulbs (OB) at the end of the treatment using a 1.5-Tesla Exite MRI system (GEMS, Milwaukee, WI, USA) with a quadrature head coil. The imaging pulse sequences included axial T1-weighted images, FLAIR images, along with axial and coronal T2-weighted fast spin-echo images. Contrast-enhanced T1-weighted images with axial and coronal sections were acquired. After a sagittal localizing scan, 2-2.5-mm-thick T2-weighted coronal and sagittal (both TR = 5,000 ms, TE = 106 ms, NEX = 2, Matrix = 256 9 256) images without an interslice gap were taken with a 12-cm field of view, as per the standardized protocol for OB analysis. OB volumes were measured using Mimics Medical 21.0 (Materialise, Leuven, Belgium).
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Sep 2018
- Primary completion21 Jun 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic AnosmiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong-San Jiang, Study chair, Departments of Medical Research, Otolaryngology, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199623
- Sponsor's protocol ID
- CF18227A
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chinese Herbal Medicine(Tailored Guizhi Decoction) as an Adjuvant Therapy in the Treatment of Traumatic Anosmia
- ClinicalTrials.gov ID
- NCT05199623
- Acronym / sponsor ID
- CF18227A
- Conditions
- Traumatic Anosmia
- Keywords
- Chinese herbal medicine, Guizhi decoction, Olfactory training, Phenyl ethyl alcohol threshold test, Traumatic anosmia, University of Pennsylvania Smell Identification Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 20 Jan 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.
Objective: To investigate the effect of Chinese herbal medicine (CHM) as an adjuvant therapy in the treatment of traumatic anosmia.
Methods: Patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (PEA) odor detection threshold remained -1 after treatment with steroid, zinc, and olfactory training (OT) for one month, were included in this study between September of 2018 and November of 2020. They were randomly divided into 2 groups, with patients in the CHM group taking CHM (tailored Guizhi decoction) and performing OT, and those in the OT group receiving OT only for 6 months. After 3 months' and 6 months' treatment, the olfactory function was evaluated by both the PEA threshold test and the traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC). Magnetic resonance imaging was performed to measure the volume of olfactory bulbs after 6 months' treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHM(Chinese herbal medicine) group | Experimental | Drug: tailored Guizhi decoction, Behavioral: Olfactory training (OT)Treatment with steroid, zinc, and olfactory training for one month. And then, take CHM(Chinese herbal medicine) (tailored Guizhi decoction) and perform OT(olfactory training) for 6 months |
| OT(olfactory training) group | Active comparator | Behavioral: Olfactory training (OT)Treatment with steroid, zinc, and olfactory training for one month. And then, perform OT(olfactory training) only for 6 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a clear history of loss of smell after an episode of head injury
- PEA threshold was -1, which is assumed to be anosmic
Key exclusion criteria (1 listed)
- One month later, they received birhinal and unirhinal PEA threshold tests. Any patient whose birhinal or unirhinal threshold was below -1 was excluded from the study.
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 |
|---|---|---|
| tailored Guizhi decoctionTailored guizhi decoction powder is a compound Chinese herbal medicine which contains 7.0g of guizhi, 1.5g of chuanxiong, 1.5g of zhimu, 1.5g of xinyi, 0.3g of mahuang, 1.0g of baizh, 2.0g of jili, 1.5g of fuling, and 1.0g of danshen. | Drug | CHM(Chinese herbal medicine) group |
| Olfactory training (OT)Four odorant bottles of PEA, lemon, eucalyptus, and clove oils were given. Patients were instructed to sniff the liquid in each bottle for 10 seconds, twice a day. | Behavioural | CHM(Chinese herbal medicine) group, OT(olfactory training) group |
Primary outcome
Olfactory test - Birhinal PEA threshold (3 months after treatment)
Time frame: Change between before treatment and 3 months after treatment
The PEA threshold test consists of different concentrations of a rose-like PEA odorant to measure the odor threshold. A 2-alternative forced-choice single-staircase procedure is used in the PEA test.
Olfactory test - Birhinal PEA threshold (6 months after treatment)
Time frame: Change between before treatment and 6 months after treatment
The PEA threshold test consists of different concentrations of a rose-like PEA odorant to measure the odor threshold. A 2-alternative forced-choice single-staircase procedure is used in the PEA test.
Olfactory test - UPSIT-TC (3 months after treatment)
Time frame: Change between before treatment and 3 months after treatment
UPSIT-TC is an odor identification test that is modified from the North American version of University of Pennsylvania Smell Identification Test(UPSIT). In the UPSIT-TC, 8 Odorants have been replaced to reflect the culture of the test-takers [20]. The UPSIT-TC is composed of 40 tests. In each test, an odorant is embedded in microcapsules and positioned on the brown bottom strips of the test page. The patient scratches the strip with a pencil tip to release the odorant. Then he or she sniffs the released odorant and chooses from a set of 4 odor descriptors to identify the odorant. The test is scored as the number of odors identified correctly
Olfactory test - UPSIT-TC (6 months after treatment)
Time frame: Change between before treatment and 6 months after treatment
UPSIT-TC is an odor identification test that is modified from the North American version of University of Pennsylvania Smell Identification Test(UPSIT). In the UPSIT-TC, 8 Odorants have been replaced to reflect the culture of the test-takers [20]. The UPSIT-TC is composed of 40 tests. In each test, an odorant is embedded in microcapsules and positioned on the brown bottom strips of the test page. The patient scratches the strip with a pencil tip to release the odorant. Then he or she sniffs the released odorant and chooses from a set of 4 odor descriptors to identify the odorant. The test is scored as the number of odors identified correctly
The volume of olfactory bulbs
Time frame: 6 months after treatment
MRI was performed to measure the volume of olfactory bulbs (OB) at the end of the treatment using a 1.5-Tesla Exite MRI system (GEMS, Milwaukee, WI, USA) with a quadrature head coil. The imaging pulse sequences included axial T1-weighted images, FLAIR images, along with axial and coronal T2-weighted fast spin-echo images. Contrast-enhanced T1-weighted images with axial and coronal sections were acquired. After a sagittal localizing scan, 2-2.5-mm-thick T2-weighted coronal and sagittal (both TR = 5,000 ms, TE = 106 ms, NEX = 2, Matrix = 256 9 256) images without an interslice gap were taken with a 12-cm field of view, as per the standardized protocol for OB analysis. OB volumes were measured using Mimics Medical 21.0 (Materialise, Leuven, Belgium).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Traumatic Anosmia
Not yet recruiting
PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
Olfactory Dysfunction, Post-traumatic Olfactory Dysfunction
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.
Rong-San Jiang study chair
Departments of Medical Research, Otolaryngology, Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tailored Guizhi decoction and Olfactory training (OT) in people with Traumatic Anosmia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jan 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory test - Birhinal PEA threshold (3 months after treatment) (time frame: Change between before treatment and 3 months after treatment). The study lists 5 primary outcomes in all. 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 20 Jan 2022.