NCT06283745 Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
| NCT ID | NCT06283745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Paraosmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-23 |
| Primary Completion | 2027-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-11-23 with a primary completion date of 2027-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia.
Eligibility Criteria
Inclusion Criteria: * Patients \>= 18 years of age * Patients who have qualitative olfactory distortion * Etiology of qualitative olfactory distortion is due to upper respiratory infection * Quantitative score under the 10th percentile on the SSParoT (HedRang and HedDir) * Quantitative score ≥ 8 on the QOD. * At least 6 months of parosmia but less than 24 months * Patients can have been previously treated with oral and topical steroids but this is not a requirement * Patients will receive concurrent olfactory training - the practice of smelling strong odors (standard of care) * Be able to read and understand English * Be able and willing to provide Informed Consent Exclusion Criteria: * Patients \< 18 years of age, pregnant females, patients who have structural abnormalities on nasal endoscopy or radiographic imaging that would prevent injection into the olfactory cleft * Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases or patients who have had olfactory loss \> 24 months * Patients with bleeding disorders or on blood thinners such as coumadin and plavix
Contact & Investigator
Zara Patel, MD
PRINCIPAL INVESTIGATOR
Stanford Otolaryngology - Head and Neck Surgery
Frequently Asked Questions
Who can join the NCT06283745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paraosmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06283745 currently recruiting?
Yes, NCT06283745 is actively recruiting participants. Contact the research team at habaya@stanford.edu for enrollment information.
Where is the NCT06283745 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06283745 clinical trial?
NCT06283745 is sponsored by Stanford University. The principal investigator is Zara Patel, MD at Stanford Otolaryngology - Head and Neck Surgery. The trial plans to enroll 40 participants.