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
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Deraya University
- 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
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
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
Soad Ali
lecturer of pharmaceutics and clinical pharmacy Deraya university
Deraya University