Clinical trial NCT04959747: Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients
Official title: Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: A Randomized, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Olfactory Dysfunction
Covid19
Keywords: olfactory dysfunction
acupuncture
COVID-19
randomized
sham controlled trial
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Tseung Kwan O Hospital, Hong Kong
name: Haven of Hope - The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Sai Kung District)
First posted: 2021-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single blinded, randomized sham controlled, cross-over clinical trial
Primary purpose: TREATMENT

Brief summary: In this a 12-week, single blinded, randomized sham controlled, and cross-over clinical trial. It will be conducted to explore the safety and efficacy of acupuncture for olfactory dysfunction in infected COVID-19 patients in Hong Kong.

Detailed description: This is a single blinded, randomized sham controlled, and cross-over clinical trial. 40 Post COVID-19 patients presenting to olfactory dysfunction will be recruited. 40 patients will be randomly assigned into 2 groups, the acupuncture group (AC) and the sham acupuncture group (SAC) with 1:1 ratio, for 4-week treatment and 2-week follow-up. After the follow-up, the sham group will be conducted with real acupuncture for another 4 weeks and the real acupuncture group will be conducted with the 4-week sham acupuncture.

Eligibility criteria: Inclusion Criteria:

Patients who have been previously diagnosed to be infected with COVID-19 and are discharged from local hospitals with all the follows: 1) post COVID-19 olfactory dysfunction with moderate or severe grades (base on UPSIT-TC scores, the cutoff scores are set at 29.5 for male and 30.5 for female); 2) post COVID-19 olfactory dysfunction who did not undergo treatment; 3) no history of trauma, injury or surgery to head or nose or any bleeding from the nose; 4) aged 18 to 80 years who are able to read and write Chinese.

Exclusion Criteria:

Patients will be excluded if they have one or more of follows: 1) patients with olfactory or gustatory dysfunctions before the COVID-19 epidemic; 2) patients with history of chronic rhinosinusitis or nasal polyposis; 3) history of nasal surgery (including rhino/septoplasty with or without functional endoscopic sinus surgery; 4) Pregnant or breastfeeding women.; 5) Medical history: cancers, conditions that affect the nervous system, such as Parkinson's disease or Alzheimer's disease, and/or any other serious diseases; 6) Unstable medical conditions; 7) Patients who have received acupuncture treatment within one month, 8) Alcoholism or drug abuse in past 1 year; 9) Have needle phobia; 10) Have known history of developing acupuncture related severe adverse reaction.

Primary outcomes:
measure: ASOF scores
timeFrame: 1, 6, 8, 12, 14 weeks
measure: sQOD-NS scores
timeFrame: 1, 6, 8, 12, 14 weeks
Secondary outcomes:
measure: UPSIT-TC
timeFrame: 0, 14 weeks
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Department of Medicine, Tseung Kwan O Hospital
name: Chi Fung CHO, Dr.
role: PRINCIPAL_INVESTIGATOR
References: