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Clinical Trials/NCT05142072
NCT05142072CompletedEarly Phase 1

Formulation, Characterization and In-vivo Evaluation of Controlled Release Intranasal Films of Vitamin D3 as an Optimistic Dosage Form for Rapid and Effective Healing of Cauterized Turbinectomy

Deraya University1 site in 1 country20 target enrollmentStarted: December 18, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Healing of cauterized tissues after surgery procedures

Study Overview

Brief Summary

One of this method's drawbacks is the healing of cauterized cartilage after processing. It was reported that the healing is so slow as no dosage form can reach this place in addition to the scares produced from healing is very irritable to the patient.

From this point, the investigators start searching for a solution to this problem and reach the repositioning of Vitamin D3 (calciferol) as an active ingredient for the rapidity and efficacy of burn healing.

The dosage form of choice that was reported before for intranasal application by the same team of investigators and gave good results. the intranasal films were proved for its convince, simplicity, efficacy, and compliance to patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • patients complain of nasal obstruction
  • do not respond to medications
  • treatment need surgery
  • patients accept following up in a timely manner for 3 weeks

Exclusion Criteria

  • no nasal polyps,
  • have problems with the surgical procedures
  • have allergy with any of the treatment components (vitamin D3 or chitosan)
  • don't follow instructions or miss the following up

Arms & Interventions

vitamin D film

Experimental

Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon

Intervention: Vitamin D3 (Drug)

control group

Other

No devices will be added

Intervention: Vitamin D3 (Drug)

Outcomes

Primary Outcomes

Healing of cauterized tissues after surgery procedures

Time Frame: three week

The outcome will be measured by endoscopic scanning pre and after application of the drug in the dosage form (representing the percent of healing) by the ENT surgeon.

Secondary Outcomes

  • Assessment of grades of healing by ENT surgeon(three weeks)
  • patients compliance from the new dosage form(three weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Soad Ali

lecturer of pharmaceutics and clinical pharmacy Deraya university

Deraya University

Study Sites (1)

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