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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07834047). StuddyBuddy aggregates publicly available trial information.