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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Olfactory Dysfunction; Post-traumatic Olfactory Dysfunction
• Intervention / Treatment: Other: Acupuncture; Drug: Oral Prednisone placebo; Drug: Corticosteroid therapy; Other: sham acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huanqin Li, Doctor; Phone Number: 0086+13521663936; Email: hqin_li@163.com
• Study Contact Backup: Name: Ruotong Zhao, Master; Phone Number: 0086+17701054857; Email: 3380884776@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital
      • Principal Investigator: Huanqin Li
      • Sub-Investigator: Xiaoyu Yan
      • Sub-Investigator: Qian Liu
      • Sub-Investigator: Mingyang Cao
      • Contact: Li Huanqin Li; Phone Number: 13521663936; Email: hqin_li@163.com
      • Contact: Huanqin Li; Phone Number: 0086+13521663936; Email: hqin_li@163.com
      • Sub-Investigator: Weiming Liu
      • Sub-Investigator: Hao Shen
      • Sub-Investigator: Ruotong Zhao
      • Sub-Investigator: Yunfei Li
      • Sub-Investigator: Mingxing Zhang
      • Sub-Investigator: Keren He
      • Sub-Investigator: Yukun Liang
      • Sub-Investigator: Jincun Lai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment arm; 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.	Other: Acupuncture; 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); Drug: Oral Prednisone placebo; 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.
Active Comparator: control arm; 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).	Drug: Corticosteroid therapy; 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.; Other: sham acupuncture; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	From enrollment to the end of treatment at 8 weeks;12 weeks after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events within 12 weeks after randomization, such as infection, pain, and other acupuncture-related complications in the Traditional Chinese Medicine Department; major adverse events will be reported until the end of the study.	From enrollment to the end of observation at 12 weeks

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Chair: Huanqin Li, Beijing Tiantan Hosital

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: September 17, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; Traumatic Brain Injury; Olfactory Dysfunction; Post-traumatic Olfactory Dysfunction; PTOD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: KY2026-208-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

Anyone who are interested in the trial can ask us to share the primary data by send a requirement through email.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No