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Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09-15
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07834047
Lead Sponsor Beijing Tiantan Hospital
Conditions Post-traumatic Olfactory Dysfunction, Traumatic Brain Injury, Olfactory Dysfunction
Enrollment 84 participants
Start Date 2026-09-15
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-22