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

Atrophic Rhinitis Clinical Trial

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 Rhinitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Atrophic Rhinitis
• Atrophy
• Rhinitis

• NCT number: NCT03112330
• Study type: Interventional
• Source: Seoul St. Mary's Hospital
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Completion date: April 1, 2019