A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis
- Conditions
- Atrophic Rhinitis
- Interventions
- Device: Plasma rich platelet injectionDevice: Saline nasal spray
- Registration Number
- NCT03112330
- Lead Sponsor
- Seoul St. Mary's Hospital
- 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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.
- Platelet related disorders
- Low serum platelet (<100,000/㎕)
- Other hematologic disorders
- Septicemia
- Take anticoagulant drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description platelet rich plasma injection group Plasma rich platelet injection To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis platelet rich plasma injection group Saline nasal spray To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis
- Primary Outcome Measures
Name Time Method The change of mucociliary clearance function using the saccharin test 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 Outcome Measures
Name Time Method The change of nasal symptoms using the Visual analog scale 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
The change of nasal symptoms using the Sino-Nasal outcome Test 20 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 Nasal Obstruction Symptom Evaluation(NOSE) Instrument 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
Trial Locations
- Locations (1)
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of