Clinical Trial: A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Single-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Patients With Atrophic Rhi

Brief Summary:

The goal of the suggested research is to develop a treatment option using platelet rich plasma injection for regeneration of atropic nasal mucosa.

Specific aims of the suggested research is to (1) access the effect of platelet rich plasma in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative treatments including saline nasal irrigation or saline nasal spray.


Detailed Summary:

Clinical trials of platelet rich plasma injection for regeneration of atropic nasal mucosa.

  • Injection interval and follow-up duration

    • Injection interval 2 weeks (upto total 3 consecutive injection)
    • Follow-up duration: 6 months

  • Observation items, clinical assessment items and evaluation method

    • Access the nasal mucosal status using nasal speculum.
    • Access the nasal mucociliary function using saccharin test (primary outcome; once per month).
    • Fill in the nasal symptom scores using Nasal Obstruction Symptom Evaluation(NOSE) Instrument, Sino-Nasal outcome Test 20, and Visual analog scale (secondary outcome; once per month)

  • The other atrophic rhinitis patients who did not want to perform platelet rich plasma injection

    • Random allocation to saline nasal irrigation or saline nasal spray group
    • Perform same observation items, clinical assessment items and evaluation method as well as platelet rich plasma injection group

Sponsor: Seoul St. Mary's Hospital

Current Primary Outcome: The change of mucociliary clearance function using the saccharin test [ Time Frame: 2, 4, 8, 12, and 24th week ]

The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in NOSE total scores of the 2, 4, 8, 12, and 24th week after first treatment
  • The change of nasal symptoms using the Sino-Nasal outcome Test 20 [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in Sino-Nasal outcome Test 20 scores of the 2, 4, 8, 12, and 24th week after first treatment
  • The change of nasal symptoms using the Visual analog scale [ Time Frame: 2, 4, 8, 12, and 24th week ]
    The change in Visual analog scale scores of the 2, 4, 8, 12, and 24th week after first treatment


Original Secondary Outcome: Same as current

Information By: Seoul St. Mary's Hospital

Dates:
Date Received: April 4, 2017
Date Started: April 17, 2017
Date Completion: April 1, 2020
Last Updated: April 12, 2017
Last Verified: April 2017