Skip to main content
OpenTrials
Completed

NCT Number: NCT03112330

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (>18 years)
  • Complaint of atrophic rhinitis symptoms including nasal crusting, nasal burning sensation, and postnasal drip
  • Atrophic rhinitis view on nasal endoscopic finding
  • Patients who informed sufficient about other atrophic rhinitis treatment options including Young's operation, lubricants, or saline irrigation, but, want more other active treatment option.

Exclusion criteria

  • Platelet related disorders
  • Low serum platelet (<100,000/㎕)
  • Other hematologic disorders
  • Septicemia
  • Take anticoagulant drugs

Treatment and study plan

Plasma rich platelet injection

Device

Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa

Saline nasal spray

Device

two puffs of isotonic saline nasal spray twice daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study 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

Acronym: ARPRP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.