A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis (ARPRP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03112330|
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrophic Rhinitis||Device: Plasma rich platelet injection Device: Saline nasal spray||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Platelet Rich Plasma Injection group : 12 patients anticipated Saline spray group : 12 patients anticipated|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 8, 2017|
|Actual Primary Completion Date :||April 1, 2019|
|Actual Study Completion Date :||April 1, 2019|
Experimental: platelet rich plasma injection group
To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis
Device: Plasma rich platelet injection
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
Device: Saline nasal spray
two puffs of isotonic saline nasal spray twice daily
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112330
|Korea, Republic of|
|Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of, 06591|
|Study Chair:||Sung Won Kim, MD, PhD||Seoul St. Mary's Hospital|
|Principal Investigator:||Do Hyun Kim, MD, PhD||Seoul St. Mary's Hospital|