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The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study

Primary Purpose

Nurse's Role, Patient Education, Foot Care

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Propholis extrate
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nurse's Role focused on measuring nursing, nurse coaching, patient education, complementary therapy, althernative therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Necmettin Erbakan Univercity

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1 (Propolis)

Group 2 (Nurse Coaching/ Nursing education)

Group 3 (Plassebo)

Arm Description

Medical therapy and propolis

Medical treatment and nurse coaching

Medical treatment and plassebo will be applied.

Outcomes

Primary Outcome Measures

Evaluation
Dermatological Quality of Life Scale

Secondary Outcome Measures

Doctor's an patient's global
Doctor's global assessment

Full Information

First Posted
December 10, 2020
Last Updated
February 1, 2023
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04789083
Brief Title
The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
Official Title
The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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. Medical treatment applied to all three groups: Sertaconazole nitrate (2%), 1x1, externally Terbinafine hydrochloride (250 mg), 1x1, oral Propolis treatment: Alcoholic extract of propolis will be used topically 2x1. Plassebe: Sterile distilled water 2x1 will be used. Plassebo and propolis extrat will be prepared in the same packages. Nurse coaching will continue by the nurse, who received coaching training, using the training booklet, with the first meeting face-to-face and subsequent calls over the phone. Interviews will be held once every two weeks.Each participant will be followed for two months. Their treatment and nurse coaching will also continue for two months. The nurse coach will coach each patient at least four times. Each coaching session will last at least 30 minutes. In the evaluation; Dermatological Quality of Life Scale will be used with the global evaluation of the patient and the doctor. Approval was obtained from Medipol University Traditional and Alternative Medicine Practices Ethics Committee for the research. Conditions and Keywords Propolis, foot care, nursing education Study Design: Randomised Controlled Trial Arms, Groups, and Interventions There are 2 experiments and 1 control group in the study. Routine antifungal therapy will be applied to all groups. Apart from this, one group will be given propolis, another group will be given plassebo. Another group will be given foot care training. Outcome Measures Doctor's global assessment Patient's global assesment Dermatological quality of life scale Eligibility The study was planned in accordance with the Turkish Ministry of Health rules. Contacts, Locations, and Investigator Information Rukiye Burucu Necmettin Erbakan Üniversitesi Seydişehir SBF Seydişehir/ Konya rburucu@hotmail.com 05062347525 IPD Sharing Statement...

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse's Role, Patient Education, Foot Care
Keywords
nursing, nurse coaching, patient education, complementary therapy, althernative therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a double blind randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Propolis)
Arm Type
Experimental
Arm Description
Medical therapy and propolis
Arm Title
Group 2 (Nurse Coaching/ Nursing education)
Arm Type
Experimental
Arm Description
Medical treatment and nurse coaching
Arm Title
Group 3 (Plassebo)
Arm Type
Placebo Comparator
Arm Description
Medical treatment and plassebo will be applied.
Intervention Type
Other
Intervention Name(s)
Propholis extrate
Other Intervention Name(s)
Nurse coaching/ Nursing education
Intervention Description
Plassebo
Primary Outcome Measure Information:
Title
Evaluation
Description
Dermatological Quality of Life Scale
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Doctor's an patient's global
Description
Doctor's global assessment
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Necmettin Erbakan Univercity
City
Konya
ZIP/Postal Code
42370
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study

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