Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04789083 |
| Other study ID # |
NecmettinErbakanU-Burucu |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2022 |
| Est. completion date |
August 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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...
