The Effect of Chinese Herbal Medicine as an Adjuvant Therapy in the Treatment of Traumatic Anosmia

Taichung Veterans General Hospital

Status

Completed

Conditions

Traumatic Anosmia

Treatments

Behavioral: Olfactory training (OT)

Drug: tailored Guizhi decoction

Study type

Interventional

Funder types

Other

Identifiers

NCT05199623

CF18227A

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

77 participants in 2 patient groups

CHM(Chinese herbal medicine) group

Experimental group

Description:

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

Treatment:

Drug: tailored Guizhi decoction

Behavioral: Olfactory training (OT)

OT(olfactory training) group

Active Comparator group

Description:

Treatment with steroid, zinc, and olfactory training for one month. And then, perform OT(olfactory training) only for 6 months.

Treatment:

Behavioral: Olfactory training (OT)