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

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ClinicalTrials.gov Identifier: NCT04789083
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Rukiye Burucu, Necmettin Erbakan University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This 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 : March 3, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (Propolis)
Medical therapy and propolis
Other: Propholis extrate
Plassebo
Other Name: Nurse coaching/ Nursing education

Experimental: Group 2 (Nurse Coaching/ Nursing education)
Medical treatment and nurse coaching
Other: Propholis extrate
Plassebo
Other Name: Nurse coaching/ Nursing education

Placebo Comparator: Group 3 (Plassebo)
Medical treatment and plassebo will be applied.
Other: Propholis extrate
Plassebo
Other Name: Nurse coaching/ Nursing education




Primary Outcome Measures :
  1. Evaluation [ Time Frame: 3 month ]
    Dermatological Quality of Life Scale


Secondary Outcome Measures :
  1. Doctor's an patient's global [ Time Frame: 3 month ]
    Doctor's global assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789083


Contacts
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Contact: Rukiye Burucu 05062347525 rburucu@hotmail.com
Contact: Hasan Karaağaç 05067723252 hasan_karaagac@hotmail.com

Locations
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Turkey
Necmettin Erbakan Univercity Recruiting
Konya, Turkey, 42370
Contact: Rukiye Burucu, Asist. Prof    05062347525    rburucu@hotmail.com   
Contact: Hasan Karaağaç, Asist. Prof    05067723252    hasan_karaagac@hotmail.com   
Sponsors and Collaborators
Necmettin Erbakan University
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Responsible Party: Rukiye Burucu, Assit. Prof., Necmettin Erbakan University
ClinicalTrials.gov Identifier: NCT04789083    
Other Study ID Numbers: NecmettinErbakanU-Burucu
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rukiye Burucu, Necmettin Erbakan University:
nursing
nurse coaching
patient education
complementary therapy
althernative therapy
Additional relevant MeSH terms:
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Tinea Pedis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Foot Dermatoses
Foot Diseases
Skin Diseases
Pruritus
Skin Manifestations