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

• Sponsor: Necmettin Erbakan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04789083
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nurse's Role; Patient Education; Foot Care	Other: Propholis extrate	N/A

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.

1. Conditions and Keywords Propolis, foot care, nursing education

2. Study Design: Randomised Controlled Trial

3. 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.

4. Outcome Measures

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

1. Eligibility The study was planned in accordance with the Turkish Ministry of Health rules.

2. Contacts, Locations, and Investigator Information Rukiye Burucu Necmettin Erbakan Üniversitesi Seydişehir SBF Seydişehir/ Konya [e-mail] 05062347525

3. IPD Sharing Statement...

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study is a double blind randomized controlled studyThis study is a double blind randomized controlled study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
• Actual Study Start Date: Mar 3, 2021
• Anticipated Primary Completion Date: Mar 30, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation [3 month]

   Dermatological Quality of Life Scale

Secondary Outcome Measures

1. Doctor's an patient's global [3 month]

   Doctor's global assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Necmettin Erbakan Univercity	Konya		Turkey	42370

Sponsors and Collaborators

• Necmettin Erbakan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rukiye Burucu, Assit. Prof., Necmettin Erbakan University
• ClinicalTrials.gov Identifier: NCT04789083
• Other Study ID Numbers: NecmettinErbakanU-Burucu
• First Posted: Mar 9, 2021
• Last Update Posted: Dec 20, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rukiye Burucu, Assit. Prof., Necmettin Erbakan University: nursing; nurse coaching; patient education; complementary therapy; althernative therapy
• Additional relevant MeSH terms: Tinea Pedis

Study Results

No Results Posted as of Dec 20, 2021