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

NCT05199623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-01-20

No results posted yet for this study

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, 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

Interventions

DRUG

tailored Guizhi decoction

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Rong-San Jiang · Departments of Medical Research, Otolaryngology, Taichung Veterans General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-06-21
Completion
2021-07-09

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199623 on ClinicalTrials.gov