NCT04717960

Brief Summary

An interventional hospital based study will be undertaken from February 2021 to February 2023 in order to determine the efficacy of platelet rich plasma as a new modality for treatment of patients suffering from atrophic rhinitis in Sohag university hospital.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

January 14, 2021

Last Update Submit

January 16, 2021

Conditions

Atrophic Rhinitis

Keywords

Atrophic rhinitis

Outcome Measures

Primary Outcomes (2)

  • Degree of change in histopathological pattern of nasal mucosa

    A nasal mucosal biopsy will be obtained in all cases. Five subheadings for histopathology; Each variable was assigned a score of 0, 1 or 2 where 0 representing normal nasal mucosal features, whereas 2 signifying extreme variation, 1. Status of epithelium: respiratory epithelium (pseudo stratified columnar ciliated epithelium, squamous metaplasia (partial/total ± keratinization); Denuded or not 2. Status of mucous cells (Normal glands / ↓ number and size / Absence) 3. Condition of blood vessels (Reduced vascularity or Dilated blood vessels / Periarteritis/ Endarteritis). 4. Tunica propria: Granulation tissue Presence of Chronic inflammatory cellular infiltrate Degree of Fibrosis Chronic inflammatory cellular infiltration with fibrosis Basement membrane (Normal / Ill-defined /Thickened) Seromucinus glands especially the serous component

    12 weeks after end of the procedure.

  • Degree of change in patient satisfaction and quality of life

    Symptom score, Sinonasal Outcome Test 25 (SNOT 25) will be noted .

    12 weeks after end of the procedure.

Secondary Outcomes (1)

  • Assess the nasal mucociliary function .

    12 weeks after end of the procedure.

Study Arms (2)

study group group (1)

ACTIVE COMPARATOR

the group which will undergo submucosal injection of platelet rich plasma

Procedure: nasal submucosal injection of platelet rich plasma

comparative group group (2)

NO INTERVENTION

patients using the usual lines of medical treatment like nasal douching and lubricants

Interventions

nasal submucosal injection of platelet rich plasmaPROCEDURE

* The selected region will be infiltrated with a cold saline solution with addition of 1 mL of adrenaline and 25 mL of 2% lignocaine per 500 mL saline. * Platelet-rich plasma is prepared by drawing 10 mL of blood sample from the patient. * The blood will be centrifuged at 1530 g for 10 min to obtain platelet-poor plasma. * This will again centrifuged at 2720 g for 10 min to get platelet-rich plasma. * Approximately 1 mL of platelet-rich plasma will be obtained from 10 mL blood. Usually amount of about 3ml is needed to be injected in each nostril at the affected sites of inferior and middle turbinates, septum and floor of the nose. Platelet rich plasma injected into the affected area after degranulating the platelet by adding 0.5 mL of calcium chloride. * Injection interval of 2 weeks (up to total 3 consecutive injections). * Follow-up duration: 4 months

study group group (1)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with primary atrophic rhinitis
  • patients with empty nose syndrome

You may not qualify if:

  • patients with secondary atrohic rhinitis except for those with empty nose syndrome
  • patients with bleeding disorders mainly platelet disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Atrophic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Marwa saad, MSc

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa saad, MSc

CONTACT

01061754045marwasaad2262@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Evaluation Of Role Of Platelet Rich Plasma In Treatment Of Patients Suffering From Atrophic Rhinitis

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share