Skip to main content
OpenTrials
Completed

NCT Number: NCT05199623

The Effect of Chinese Herbal Medicine 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Anosmia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a clear history of loss of smell after an episode of head injury
  • PEA threshold was -1, which is assumed to be anosmic

Exclusion criteria

  • 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.

Treatment and study plan

tailored Guizhi decoction

Drug

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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).

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

The Effect of Chinese Herbal Medicine(Tailored Guizhi Decoction) as an Adjuvant Therapy in the Treatment of Traumatic Anosmia

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2022
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.