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

February 1, 2023 updated by: Rukiye Burucu, Necmettin Erbakan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Study Identification: Randomised Controlled Trial
  2. Study Status: This will begin
  3. Sponsor/Collaborators: SBS Scientific Bio Solutions Inc.
  4. 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

  5. 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.

  6. Conditions and Keywords Propolis, foot care, nursing education
  7. Study Design: Randomised Controlled Trial
  8. 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.

  9. Outcome Measures

    Doctor's global assessment Patient's global assesment Dermatological quality of life scale

  10. Eligibility The study was planned in accordance with the Turkish Ministry of Health rules.
  11. Contacts, Locations, and Investigator Information Rukiye Burucu Necmettin Erbakan Üniversitesi Seydişehir SBF Seydişehir/ Konya rburucu@hotmail.com 05062347525
  12. IPD Sharing Statement...

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42370
        • Necmettin Erbakan Univercity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (Propolis)
Medical therapy and propolis
Other: Propholis extrate
Plassebo
Other Names:
  • Nurse coaching/ Nursing education
Experimental: Group 2 (Nurse Coaching/ Nursing education)
Medical treatment and nurse coaching
Other: Propholis extrate
Plassebo
Other Names:
  • Nurse coaching/ Nursing education
Placebo Comparator: Group 3 (Plassebo)
Medical treatment and plassebo will be applied.
Other: Propholis extrate
Plassebo
Other Names:
  • Nurse coaching/ Nursing education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation
Time Frame: 3 month
Dermatological Quality of Life Scale
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doctor's an patient's global
Time Frame: 3 month
Doctor's global assessment
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Actual)

August 19, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NecmettinErbakanU-Burucu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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