Post-traumatic Olfactory DysfunctionNCT07834047
Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial
A study testing Acupuncture and Corticosteroid therapy in people with Post-traumatic Olfactory Dysfunction and Traumatic Brain Injury, run by Beijing Tiantan Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-traumatic Olfactory Dysfunction, Traumatic Brain Injury, Olfactory Dysfunction
- What is being tested?
- Acupuncture and Corticosteroid therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2026to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Li Huanqin Li, 13521663936, hqin_li@163.com
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Huanqin Li, 0086+13521663936, hqin_li@163.com
Huanqin Li
About this study
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:
Read more
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.
- Being tested
- Acupuncture, Corticosteroid therapy, sham acupuncture, Oral Prednisone placebo
- Keywords
- Post-traumatic Olfactory Dysfunction, PTOD, acupuncture, Olfactory Dysfunction, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupoint selection:
Fengchi (GB20, bilateral, quick needling), Jingbailao (bilateral, quick needling), Dazhuipang (bilateral, quick needling); Shenting (DU24), Baihui (DU20), Yingxiang penetrating Bitong (bilateral), Quanliao penetrating Bitong (bilateral), Hegu (LI4, bilateral), Wailaogong (bilateral), Zusanli (ST36, bilateral), Taichong (LR3, bilateral).
Procedure:
The patient is first seated upright. Quick needling (without needle retention) is performed at Fengchi, Jingbailao, and Dazhuipang. Then the patient assumes a supine position. Needles are inserted at Shenting, Baihui, Wailaogong, and Taichong, while deep needling is applied at Yingxiang penetrating Bitong, Quanliao penetrating Bitong, Hegu, and Zusanli. After achieving deqi (needle sensation), the needles are retained for 20 minutes.
Course of treatment:
Acupuncture is given 3 times per week for 4 weeks (total 12 sessions)
Corticosteroid therapyDrug
Oral prednisone given as a short-term course (4 weeks). Dosage and tapering schedule: Week 1: 30 mg/d; Week 2: 15 mg/d; Week 3: 10 mg/d; Week 4: 5 mg/d, then discontinued after 4 weeks.
sham acupunctureOther
Sham acupuncture: Park sham acupuncture device (placebo needle) is used. The acupoint selection and operation sites are the same as those in the treatment group. After routine disinfection, the needle holder is applied to the acupoint, and the needle is inserted into the holder without penetrating the skin, and retained for 20 minutes. The treatment course is the same as the treatment group (3 times per week for 4 weeks).
Oral Prednisone placeboDrug
The placebo tablets were manufactured to be identical in appearance (color, size, shape) and taste to the active prednisone tablets, ensuring effective blinding. Participants received the placebo orally according to the same tapering regimen as the control group: 30 mg/day (as equivalent tablet count) for week 1, 15 mg/day for week 2, 10 mg/day for week 3, and 5 mg/day for week 4, after which the medication was discontinued. The total course lasted 4 weeks, matching the duration of both the active prednisone therapy and the acupuncture sessions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | The treatment group includes two interventions: acupuncture and a steroid placebo (prednisone placebo).
Acupoint selection: Fengchi (GB20, bilateral, quick needling), Jingbailao (bilateral, quick needling), Dazhuipang (bilateral, quick needling); Shenting (DU24), Baihui (DU20), Yingxiang penetrating Bitong (bilateral), Quanliao penetrating Bitong (bilateral), Hegu (LI4, bilateral), Wailaogong (bilateral), Zusanli (ST36, bilateral), Taichong (LR3, bilateral).
Procedure: First, the patient sits upright. Quick needling (without retaining needles) is performed at Fengchi, Jingbailao, and Dazhuipang. Then, the patient assumes a supine position. Needles are inserted Shenting, Baihui, etc.while deep needling is performed at Yingxiang penetrating Bitong, Quanliao penetrating Bitong, Hegu, and Zusanli. After achieving deqi (needle sensation), the needles are retained for 20 minutes.
Course: 3×/week for 4 weeks (12 sessions). Oral prednisone placebo at same dose/duration as control group. Receives: Other: Acupuncture; Drug: Oral Prednisone placebo |
| control arm | Active comparator | Medication: Oral prednisone given as a short-term course (4 weeks). Dosage and tapering schedule: Week 1: 30 mg/d; Week 2: 15 mg/d; Week 3: 10 mg/d; Week 4: 5 mg/d, then discontinued after 4 weeks.
Sham acupuncture: Park sham acupuncture device (placebo needle) is used. The acupoint selection and operation sites are the same as those in the treatment group. After routine disinfection, the needle holder is applied to the acupoint, and the needle is inserted into the holder without penetrating the skin, and retained for 20 minutes. The treatment course is the same as the treatment group (3 times per week for 4 weeks). Receives: Drug: Corticosteroid therapy; Other: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of the CSIT score at 4 weeks
Improvement rate of the CSIT score at 4 weeks.The olfactory identification test is the Chinese Smell Identification Test (CSIT), developed by the Human Olfaction Laboratory, Institute of Psychology, Chinese Academy of Sciences, based on the Chinese population. It contains 40 odor items familiar to the Chinese population and has a 6-month test-retest reliability of 0.92.If the CSIT score improves by 4 points or more, this indicates an improvement in olfactory function.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (4)
Improvement rate of the CSIT score at 12 weeks
Rate of improvement in olfactory identification test scores after 12 weeks,The olfactory identification test is the Chinese Smell Identification Test (CSIT), developed by the Human Olfaction Laboratory, Institute of Psychology, Chinese Academy of Sciences, based on the Chinese population. It contains 40 odor items familiar to the Chinese population and has a 6-month test-retest reliability of 0.92.If the CSIT score improves by 4 points or more, this indicates an improvement in olfactory function.
Measured: at 12 weeks after enrollment
olfactory threshold scores
It measures the lowest concentration level that the patient can perceive, assessing sensitivity in detecting odors. It targets the peripheral olfactory nerves. It includes 20 concentration-graded odor sticks (of the same odor) and a baseline odor stick (nearly odorless). The patient smells one graded odor stick and one baseline odor stick sequentially and compares which odor is stronger.
Measured: From enrollment to the end of treatment at 4 weeks；12 weeks after enrollment
subjective olfactory function
The visual analogue scale (VAS, 0-100) in the olfactory disorder scale was used to rate the severity of olfactory loss, where 0 indicates normal olfaction and 100 indicates complete loss of smell. According to other published studies, the severity of olfactory loss was categorized as mild (0-30), moderate (31-70), and severe (>70).
Measured: From enrollment to the end of treatment at 8 weeks;12 weeks after enrollment
Emotional and psychological assessment
Emotional and psychological assessment will be conducted using the Hamilton Anxiety Scale (HAMA), the 17-item Hamilton Depression Scale (HAMD17), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Patient Health Questionnaire-9 (PHQ-9) to evaluate patients' emotional and psychological status.
Measured: From enrollment to the end of treatment at 8 weeks;12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Olfactory DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huanqin Li, Study chair, Beijing Tiantan Hosital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834047
- Sponsor's protocol ID
- KY2026-208-02
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes We plan to publish a protocol of this trial in about 6-8 months after the registration, and one paper of the trial including results in a high-impact peer reviewed journal in one year after the trial. About two years after the end of this trial and our open publication of the result, the primary data and type of analysis will be available for 5-10 years until data updated by a more specific study with larger number of participants. Anyone who are interested in the trial can ask us to share the primary data by send a requirement through email. We provide the collected primary data without no real information of participants, all the data sequence will be numbered instead of real names.