Protocol summary

Study aim
Evaluation of the effectiveness and effect of synergism including semi-solid containing sucralfate, zinc oxide, aloe vera gel and peppermint essential oil and animal oil
Design
Clinical trial with control group, community-based and pragmatic, with parallel group, double-blind, randomized, design of 60 patients.
Settings and conduct
This study was performed on infants and children up to 24 months who suffered from diaper rash and referred to the office of Dr.Seighali located on Sattar Khan Street. zinc oxide, aloe vera gel powder, mint essential oil and the second group examines animal oil. According to similar pilot studies, the study population consists of 60 people, and each of The first and second experimental groups and 20 control groups. Patients participate in the study based on the physician's diagnosis of urinary incontinence and according to the patient's demographic information and parents consent, and are placed in one of the control or experimental groups. A pre-prepared informed consent form will also be provided to patients to become fully acquainted with the study process. The benefits of this study can be applied to children.
Participants/Inclusion and exclusion criteria
Inclusion criteria: doctors diagnosis of diaper rash, age range from birth to 24 months, Written consent and parental cooperation. Exclusion criteria: skin infection - fever- parental lake of cooperation.
Intervention groups
Control group: includes 20 children with age range from birth to 24 months with diaper rash, who are treated for 7 days with our desired drug, which contains sucralfate, zinc, peppermint essential oil and aloe vera gel. Intervention group: The same as the control group, except that they are treated with a placebo that contains zinc.
Main outcome variables
comparison of the severity of burns, frequency of diaper changes and urination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100119003106N42
Registration date: 2022-07-05, 1401/04/14
Registration timing: prospective

Last update: 2022-07-05, 1401/04/14
Update count: 0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of topical semi-solid product containing sucralfate, zinc oxide, aloe Vera gel and peppermint essential oil and zinc oxide ointment in natural base containing Ghee oil and comparison with standard treatment containing zinc oxide in normal base in the process of healing and treatment of diaper rash: a pilot study And parallel
Public title
Evaluation of therapeutic effect of topical semi-solid product containing sucralfate, zinc oxide, aloe Vera gel and peppermint essential oil and zinc oxide ointment in natural base containing Ghee oil and comparison with standard treatment containing zinc oxide in normal base in the process of healing and treatment of diaper rash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Doctor's diagnosis of having diaper rash Age between one day to 24 months Parental consent to cooperate and use medication
Exclusion criteria:
Existence of deep ulcers, infection or fungal lesions, need for treatment with other drugs such as corticosteroids and antibiotics. Bloody stools Fever Underlying diseases History of allergies to topical products containing zinc, aloe Vera or products contains essential oil of mint, and cow's milk protein
Age
From 1 day old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Zu diesem Zweck werden 60 Umschläge (20 mit der ersten Arzneimittelkarte und 20 mit der zweiten Arzneimittelkarte und 20 mit der Placebokarte) vorbereitet. Umschläge sind mit Nummern von 1 bis 40 gekennzeichnet. Die Patienten werden nach dem Öffnen des versiegelten Umschlags einer von zwei Medikamenten- bzw. Placebogruppen, Nummer 1 bis 40, zugeordnet.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, physicians, researcher and data collector (student) don’t know about who was receiving the placebo and who receiving a placebo. The informed consent was obtained from patients and they were informed that they could leave the trial at any time. The coding of the medicine boxes was done by a third party who was not involved in the study and at the end of the study, decryption took place. All tubes of the drug are the same in terms of design and color, while the cover of the prescribed tubes is coded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Pharmaceutical Sciences Branch
Street address
Islamic Azad University, Pharmaceutical Sciences Branch, Dr. Shariati Ave., Qolhak., Yakhchal St., Yasaman Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.IAU.TMU.REC.1400.317

Health conditions studied

1

Description of health condition studied
Diaper rash
ICD-10 code
L22
ICD-10 code description
Diaper dermatitis

Primary outcomes

1

Description
Diaper Dermatitis Grading Scale.
Timepoint
The beginning of the study (before the intervention) and the second, fourth, sixth days and after the intervention
Method of measurement
Diaper Dermatitis Grading Scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first intervention group of patients receiving medicine containing zinc oxide and sucralfate and aloe vera gel and peppermint essential oil (made by Pharm.D. students in pharmaceuticals lab in Azad university) for 7 days after each diaper change.
Category
Treatment - Drugs

2

Description
Intervention group: the second intervention group received animal oil made by researchers of the Faculty of Pharmacy of Tehran Azad University of Medical Sciences for 7 days after each diaper change
Category
Treatment - Drugs

3

Description
Control group: Patients take placebo medicine made by researchers of the Faculty of Pharmacy of Tehran Azad University of Medical Sciences, which contains zinc oxide and the usual base for 7 days after each diaper change.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Fariba Seighali , private clinic
Full name of responsible person
Dr. Fariba Seighali
Street address
No. 29, corner of Sarvanaz Boulevard, Patrice Lumumba St., Sattarkhan St, Tehran.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 6656 8652
Email
faribaseighali@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
hashemian.f@iaups.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elaheh Shaban
Position
Pharm.D. candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
shabanelahe@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Position
Pharm.D., BCPS, Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0599
Email
hashemian.f@iaups.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elaheh Shaban
Position
Pharm.D. candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
shabanelahe@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data potentially can be shared after being unidentifiable.
When the data will become available and for how long
Just after the articles publication.
To whom data/document is available
For all investigators.
Under which criteria data/document could be used
The person requesting the data should be a relevant expert in this field - All statistical analyzes performed can be provided - Information can be used by mentioning the name of the research and referencing the site to the research - Requirements: Mentioning the name of the research and codes Relevant research and all the required information as well as the name of the researcher and communication channels in case of receiving the required information.
From where data/document is obtainable
Application can refer to the Department of Clinical Pharmacy, Faculty of pharmacy, Tehran Medical Science, Islamic Azad University, Dr. Hashemian or contact the researcher by sending email to shabanelahe@gmail.com or calling 09210907926.
What processes are involved for a request to access data/document
Application can apply for research information by visiting the department or by contacting the e-mail address and telephone number as well as providing information on academic studies and the purpose of requesting the information. Applicant must commit themselves to mention the source. If the request is sent six months after the publication of research information the researcher will send the data to the requesting party by email within a week.
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