The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Necmettin Erbakan University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Evaluation
Study Overview
Brief Summary
Tineapedis is an important health problem. Providing foot care in tinea pedis treatment contributes positively to the treatment. In addition, alternative treatments can also be used. In this study, the randomization study group will be divided into three. Medical treatment and foot care training will be applied to the first group, medical treatment and propolis to the second group, medical treatment and plassebo to the control group. Foot care training will be given by nurse coaching. Times of all three groups and their response to treatment will be evaluated.
Detailed Description
- Study Identification: Randomised Controlled Trial
- Study Status: This will begin
- Sponsor/Collaborators: SBS Scientific Bio Solutions Inc.
- Oversight: Patients will be given foot care training. At the same time, a phone call will be provided by the research nurse every week. Evaluation will be made at the end of 2 months
- Study Description
It was planned as a double-blind randomized controlled study. The person conducting the randomizer, the person making the statistics and the person performing the medical examiner will be blinded. Power analysis was made using the G * Power (3.1.9.4) program, 0.05 margin of error and 85% power were accepted. A total of 96 people were divided into three groups. Groups were composed of 36 people, including 10% losses for each group.
Inclusion Criteria:
Not being pregnant Not being breastfeeding Not having confusion Not being immunosuppressed Not using systemic cortisone Not having any dermatological problems (psoriasis, contact dermatitis, etc.) that will affect the treatment.
Agree to participate in research Being accessible by phone Having no problems communicating by phone Not having problems with physical care
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Not being pregnant
- •Not being breastfeeding
- •Not having confusion
- •Not being immunosuppressed
- •Not using systemic cortisone
- •Not having any dermatological problems (psoriasis, contact dermatitis, etc.) that will affect the treatment.
- •Agree to participate in research
- •Being accessible by phone
- •Having no problems communicating by phone
- •Not having problems with physical care
Exclusion Criteria
- •Pregnant / nursing women
- •Using systemic antifungal therapy
- •Using systemic croticosteroids
- •In the process of treatment for oncological reasons
- •Are using immunosuppressants
- •Dermatological disease (contact dermatitis, psoriasis)
- •Under the age of 18 and over the age of 64
- •Have cognitive problems
- •There is no telephone / telephone number within reach
- •Individuals who have difficulties in speaking and understanding Turkish will be excluded from the study.
Arms & Interventions
Group 1 (Propolis)
Medical therapy and propolis
Intervention: Propholis extrate (Other)
Group 2 (Nurse Coaching/ Nursing education)
Medical treatment and nurse coaching
Intervention: Propholis extrate (Other)
Group 3 (Plassebo)
Medical treatment and plassebo will be applied.
Intervention: Propholis extrate (Other)
Outcomes
Primary Outcomes
Evaluation
Time Frame: 3 month
Dermatological Quality of Life Scale
Secondary Outcomes
- Doctor's an patient's global(3 month)
Investigators
Rukiye Burucu
Assit. Prof.
Necmettin Erbakan University