A Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Atrophic Rhinitis
NCT ID: NCT03112330
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2017-06-08
2019-04-01
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Plasma rich platelet injection
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
Saline nasal spray
two puffs of isotonic saline nasal spray twice daily
Interventions
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Plasma rich platelet injection
Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
Saline nasal spray
two puffs of isotonic saline nasal spray twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
* Low serum platelet (\<100,000/㎕)
* Other hematologic disorders
* Septicemia
* Take anticoagulant drugs
19 Years
ALL
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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Sung Won Kim
Professor
Principal Investigators
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Sung Won Kim, MD, PhD
Role: STUDY_CHAIR
Seoul St. Mary's Hospital
Do Hyun Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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References
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Friji MT, Gopalakrishnan S, Verma SK, Parida PK, Mohapatra DP. New regenerative approach to atrophic rhinitis using autologous lipoaspirate transfer and platelet-rich plasma in five patients: Our Experience. Clin Otolaryngol. 2014 Oct;39(5):289-92. doi: 10.1111/coa.12269. No abstract available.
Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
Hildenbrand T, Weber RK, Brehmer D. Rhinitis sicca, dry nose and atrophic rhinitis: a review of the literature. Eur Arch Otorhinolaryngol. 2011 Jan;268(1):17-26. doi: 10.1007/s00405-010-1391-z. Epub 2010 Sep 29.
Mishra A, Kawatra R, Gola M. Interventions for atrophic rhinitis. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008280. doi: 10.1002/14651858.CD008280.pub2.
Jaswal A, Jana AK, Sikder B, Nandi TK, Sadhukhan SK, Das A. Novel treatment of atrophic rhinitis: early results. Eur Arch Otorhinolaryngol. 2008 Oct;265(10):1211-7. doi: 10.1007/s00405-008-0629-5. Epub 2008 Mar 4.
Modrzynski M. Hyaluronic acid gel in the treatment of empty nose syndrome. Am J Rhinol Allergy. 2011 Mar-Apr;25(2):103-6. doi: 10.2500/ajra.2011.25.3577.
Canciani M, Barlocco EG, Mastella G, de Santi MM, Gardi C, Lungarella G. The saccharin method for testing mucociliary function in patients suspected of having primary ciliary dyskinesia. Pediatr Pulmonol. 1988;5(4):210-4. doi: 10.1002/ppul.1950050406.
Stavrakas M, Karkos PD, Markou K, Grigoriadis N. Platelet-rich plasma in otolaryngology. J Laryngol Otol. 2016 Dec;130(12):1098-1102. doi: 10.1017/S0022215116009403.
Other Identifiers
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CMCENT-01
Identifier Type: -
Identifier Source: org_study_id
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