IRCT | Assessment of the therapeutic effects of Anaheal plus supplement in patients with contact dermatitis

#	Registration date	Revision Id
2	2023-11-04, 1402/08/13	284401
1	2023-08-21, 1402/05/30	276147

Protocol summary

Study aim: Investigating the therapeutic effect of Anahil Plus supplement in patients with contact dermatitis
Design: clinical trial with control groups, community-based and pragmatic, with a parallel group, single-blind, randomized, on 50 patients
Settings and conduct: This study was performed on patients over 12 years old with contact dermatitis who reffered to the Tehran Islamic Azad University Hospitals , and the first group will receive Anahil Plus, which contains bromelain and curcumin, and the second group will receive a placebo that contains lactose . The number of patients is 50, which was announced by a statistician based on the number of patients with contact dermatitis who visited the office in the last year and in a period of three months. Each of the experimental and control groups includes 25 people. Patients will participate in the study according to the doctor's diagnosis of having contact dermatitis and according to demographic information and personal consent and will be placed in one of the control or experimental groups. The informed consent form that has been prepared in advance will be provided to the patients so that they are fully familiar with the study process.
Participants/Inclusion and exclusion criteria: Adult patients (over 12 years old) with contact dermatitis; Allergy to pineapple, celery, carrot and fennel, having hemophilia, taking two anti-platelet drugs or one anti-platelet drug and an anticoagulant, severe kidney failure (GFR<30), severe liver failure (Child pugh B, C), Pregnant, lactating women
Intervention groups: Adult patients with contact dermatitis who will receive Anahil Plus supplement in addition to standard treatment (moisturizer).In control group in addition to the standard treatment, they will receive a placebo that contains lactose.
Main outcome variables: The surface of the affected area, redness, inflammation, itching

General information

Reason for update: The code of ethics and sponsor was entered incorrectly
Acronym
IRCT registration information: IRCT registration number: IRCT20150706023084N16

Registration date: 2023-08-21, 1402/05/30

Registration timing: prospective

Last update: 2023-11-06, 1402/08/15

Update count: 1
Registration date: 2023-08-21, 1402/05/30

Registrant information: Name

MARYAM SHIEHMORTEZA

Name of organization / entity

AZAD UNIVERSITY PHARMACEUTICAL SCIENCES

Country

Iran (Islamic Republic of)

Phone

+98 212640056

Email address

shiehmorteza@iaups.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-08-23, 1402/06/01
Expected recruitment end date: 2023-11-22, 1402/09/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Assessment of the therapeutic effects of Anaheal plus supplement in patients with contact dermatitis

Public title: Anaheal plus supplement in contact dermatitis
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Adult patients (over 12 years old) Patient with contact dermatitis

Exclusion criteria:

Allergy to pineapple, celery, carrot and fennel having hemophilia taking two anti-platelet drugs or one anti-platelet drug and an anticoagulant severe kidney failure (GFR<30) severe liver failure (Child pugh B, C) Pregnancy lactation
Age: From 12 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Data analyser

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

After the diagnosis of the disease by the dermatologist, using the rand number site, each patient was assigned a number.

Blinding (investigator's opinion)

Single blinded

Blinding description

This study is conducted in single blind way, so that the patients are not aware of the contents of the received packages that contain Bremelin and Curcumin or placebo. Conventionally, the packages containing supplement number one and the packages containing placebo number two. We attribute Using rand number, we determine whether to give medicine or placebo to each patient.

Placebo

Used

Assignment

Parallel

Other design features

For all patients (both test group and control group), we prescribe the standard treatment that is moisturizing. In addition to the standard treatment, the test group also receives Anahil Plus supplement twice a day. The control group will receive a placebo instead of a supplement. After a month, we will re-examine the factors of the involvement level, redness, inflammation and itching.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical

Street address

Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch

City

Tehran

Province

Tehran

Postal code

193956466
Approval date: 2023-05-24, 1402/03/03
Ethics committee reference number: IR.IAU.PS.REC.1402.101

Health conditions studied

1

Description of health condition studied: Irritant contact dermatitis
ICD-10 code: L24.9
ICD-10 code description: Irritant contact dermatitis, unspecified cause

Primary outcomes

1

Description: The surface of the affected area
Timepoint: 30 days
Method of measurement: Measuring with a ruler

2

Description: Redness
Timepoint: 30 days
Method of measurement: According to REEDA

3

Description: Edema
Timepoint: 30 days
Method of measurement: According to REEDA

4

Description: itching
Timepoint: 30 days
Method of measurement: Ask the patient

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: including 25 patients who are diagnosed with contact dermatitis by a dermatologist and consume Anahil Plus supplement produced by the company (two tablets daily) plus moisturizer as a standard treatment for 30 days. The questionnaire form is filled at the beginning and after one month.
Category: Treatment - Drugs

2

Description: Control group:includes 25 patients who are diagnosed with contact dermatitis by a dermatologist and use standard moisturizer as a treatment for 30 days along with a placebo containing lactose. The relevant questionnaire is filled at the beginning and 30 days later.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Booali hospital

Full name of responsible person

Hanieh Jalalian Targhi

Street address

Damavand Street, not reaching Imam Hossein Square, Bu Ali Hospital

City

Tehran

Province

Tehran

Postal code

1711734365

Phone

+98 21 3334 8036

Email

Booali.hospital96@gmail.com

1

Sponsor: Name of organization / entity

Parmoon Salamat Amin Pharmaceutical Company

Full name of responsible person

Mohammad Reza Anbiaei

Street address

West Nafisi Alley, Baradaran Sarafha St, Saadat Abad Ave

City

Tehran

Province

Tehran

Postal code

1998863174

Phone

+98 21 8869 1099

Email

Info@spameda.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Parmoon Salamat Amin Pharmaceutical Company
Proportion provided by this source: 100
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: Industry

Person responsible for general inquiries

Contact: Name of organization / entity

Islamic Azad University

Full name of responsible person

Maryam Shiehmorteza

Position

Assistant professor

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

No.99, Yakhckal street, DR Shariati Avenue

City

Tehran

Province

Tehran

Postal code

1916893813

Phone

+98 21 2264 0056

Fax

Email

Shiehmorteza@iaups.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Islamic Azad University

Full name of responsible person

Maryam Shiehmorteza

Position

Associated professor

Latest degree

Specialist

Other areas of specialty/work

Medical Pharmacy

Street address

No.99, Yakhchal street, Dr Shariati Avenue

City

Tehran

Province

Tehran

Postal code

1916893813

Phone

+98 21 2264 0056

Email

Shiehmorteza@iaups.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Islamic Azad University

Full name of responsible person

Hanieh Jalalian Targhi

Position

Pharmacy student

Latest degree

A Level or less

Other areas of specialty/work

Medical Pharmacy

Street address

No.99, Yakhchal street, Dr. Shariati avenue

City

Tehran

Province

Tehran

Postal code

1916893813

Phone

+98 21 2264 0056

Email

Hjalaliant@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: Data are collected in the form of a questionnaire
When the data will become available and for how long: After the intervention
To whom data/document is available: Qualified persons
Under which criteria data/document could be used: Used foe scientific advancement in the field under study
From where data/document is obtainable: Clinical office of Islamic Azad University,Medical science of tehran, Faculty of pharmacy
What processes are involved for a request to access data/document: Request in writing by going through legal procedures.
Comments

Assessment of the therapeutic effects of Anaheal plus supplement in patients with contact dermatitis

Help:

General information

Ethics committees

#1

Primary outcomes

#1

#2

#3

#4

#5

#6

Recruitment centers

#1

Protocol summary

General information

Secondary Ids

Ethics committees

1

Health conditions studied

1

Primary outcomes

1

2

3

4

Secondary outcomes

Intervention groups

1

2

Recruitment centers

1

1

Person responsible for general inquiries

Person responsible for scientific inquiries

Person responsible for updating data

Sharing plan

Assessment of the therapeutic effects of Anaheal plus supplement in patients with contact dermatitis

Help:

General information

Ethics committees

#1

Primary outcomes

#1

#2

#3

#4

#5

#6

Recruitment centers

#1

Sponsors / Funding sources

#1

Protocol summary

General information

Secondary Ids

Ethics committees

1

Health conditions studied

1

Primary outcomes

1

2

3

4

Secondary outcomes

Intervention groups

1

2

Recruitment centers

1

Sponsors / Funding sources

1

Person responsible for general inquiries

Person responsible for scientific inquiries

Person responsible for updating data

Sharing plan