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NCT07834047
Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial
Conditions: Post-traumatic Olfactory Dysfunction, Traumatic Brain Injury, Olfactory Dysfunction
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tiantan Hospital Beijing Beijing Municipality
Summary
The goal of this clinical trial is to learn if acupuncture based on the "Form-Qi-Spirit" theory works to treat post-traumatic olfactory dysfunction in adults. It will also learn about the safety of this acupuncture treatment.
The main questions it aims to answer are:
Is the efficacy of 4-week acupuncture treatment superior to 4-week steroid treatment for post-traumatic olfactory dysfunction?
What medical problems or side effects do participants have when receiving acupuncture?
Researchers will compare real acupuncture plus a placebo (a look-alike pill with no active drug) to sham acupuncture (non-penetrating placebo needles) plus low-dose oral steroids (prednisone) - to see if the real acupuncture strategy works better than the steroid strategy for post-traumatic olfactory dysfunction.
Participants will:
Receive real acupuncture + placebo pills, OR sham acupuncture + low-dose prednisone, for 4 weeks
Undergo acupuncture/sham sessions 3 times per week (12 sessions in total)
Take the assigned pills daily (with tapering doses over 4 weeks)
Visit the clinic for smell tests, psychological assessments, and safety checks at baseline, at 4 weeks (end of treatment), and at 12 weeks (8 weeks after treatment ends)
Let me know if you need a more detailed version or any adjustments.
Eligibility Criteria
Inclusion Criteria:
* Patients with post-traumatic olfactory dysfunction who meet the diagnostic criteria;
* Aged 18-60 years;
* Subjects who have given informed consent and voluntarily participate and sign the informed consent form;
* Have not received acupuncture treatment, olfactory disorder-related medications (such as intranasal corticosteroids or oral drugs), or olfactory training within the past 1 month;
* Are in a stable post-traumatic condition without severe complications, and are able to cooperate with diagnosis, treatment, and evaluation.
Exclusion Criteria:
* Patients with a clear history of viral infection or exposure to irritant substances prior to the onset of olfactory dysfunction;
* History of nasopharyngeal tumor, or presence of active nasal diseases (sinusitis, nasal polyposis, atrophic rhinitis, allergy), as well as severe nasal obstruction caused by nasal stenosis or deformity;
* History of chemotherapy or treatment with estrogen inhibitors (aromatase inhibitors), or prior use of medications known to be harmful to olfactory function before the onset of olfactory dysfunction;
* Patients with cognitive impairment and neurodegenerative diseases (Alzheimer's disease and Parkinson's disease), or severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, olfactory hallucinations);
* Current use of medications that may affect olfaction (e.g., antidepressants and antihistamines);
* Allergy to prednisone;
* Pregnant or lactating women.
Source: ClinicalTrials.gov (NCT07834047). StuddyBuddy aggregates publicly available trial information.