Protocol summary

Study aim
The purpose of using these plants is : combating for hair loss, increasing its regrowth by increasing blood circulation, providing nutrients for the activity of hair follicles and coming out of the resting stage.
Design
This research is a clinical double blind trail that 150 patients with the diagnosis of Alopecia areata referred to the Skin and Hair Clinic
Settings and conduct
Physician examination and survey by questionnaire
Participants/Inclusion and exclusion criteria
Inclusion: Suffering from total hair loss, alopecia in the head area, size of the lesion below 10 square centimeters, completing the consent form and agreeing to participate in the study, patients aged 18 to 60 years Exclusion: Patient unsatisfaction, pregnancy during the study, a lactating woman, universal alopecia areata, ophiiasis alopecia areata, sensitivity to triamcinolone, minoxidil or herbal combination before treatment, receiving oral or topical و Special patients, patients with migraine and epilepsy
Intervention groups
Men treated with minoxidil and herbal cream prepared daily and checked up by a doctor monthly - Women with alopecia areata (AA) who are treated with minoxidil and herbal cream prepared daily and checked-up by a doctor monthly Description Patients in case group received Glycyrrhiza glabra tablets, 2 tablets three times per day
Main outcome variables
The full growth in the empty file.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220818055740N3
Registration date: 2023-02-28, 1401/12/09
Registration timing: retrospective

Last update: 2023-02-28, 1401/12/09
Update count: 0
Registration date
2023-02-28, 1401/12/09
Registrant information
Name
Nahid Jivad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3335 1031
Email address
jivad@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2018-10-07, 1397/07/15
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-03-06, 1397/12/15
Scientific title
Title : Clinical evaluation of the effect of the combination of herbal cream containing Rosmarinus officinalis, , Malva sylvestris, Foeniculum vulgare extract and Oenothera biennis and Bitter Almond Oil for treatment of hair loos on patients with Areata Alopecia
Public title
Title : Clinical evaluation of the effect of the combination of herbal cream containing Rosmarinus officinalis, , Malva sylvestris, Foeniculum vulgare extract and Oenothera biennis and Bitter Almond Oil for treatment of hair loos on patients with Areata Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent for participation in the study hair loos on patients with Areata Alopecia
Exclusion criteria:
Having no satisfaction to participate in this study Having no suffering from hair loos on patients with Areata Alopecia
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 150
Actual sample size reached: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were 150 patients and were selected by simple random sampling and Random assignment or random placement that is an experimental technique for assigning human participants or animal subjects to different groups in an experiment (e.g., a treatment group versus a control group) using randomization, such as by a chance procedure (e.g., flipping a coin). This ensures that each participant or subject has an equal chance of being placed in any group. Moreover, grouping of samples has been done using Randomizer(RA) software. Patients were divided into 6 groups of 25. For each treated group, a control group (triamcinolone cream) was placed separately, and the entrance of patients into these groups is random. Grouping of samples has been done using RA software. The blinding of this research is on behalf of the patient and the drug distributor. The homogenization of the studied groups is based on the variables: sex, age, type of alopecia areata and severity of hair loss in the head area. In general, randomization of patients was done based on coding.
Blinding (investigator's opinion)
Double blinded
Blinding description
The single blindness of the study was performed in this process that at first the mentioned drugs received code without any labels and the patient selected one of the two drugs randomly. Then, the name of each person and the drug code provided to him registered by the secretary. Neither the patient nor the doctor was not aware of the type of medication. The name of each person and his drug was specified only during analyzing the data, and completed the patients' information profile by mentioning the name of the drug received by them.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrekord Univercity of Medical Sciences
Street address
Shahrekord - Kashani Street - Shahrekord Univercity of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
R.SKUMS.REC.1397.101

Health conditions studied

1

Description of health condition studied
Hair loss in patients with alopecia areata
ICD-10 code
(L80-L99)
ICD-10 code description
(L00-L99)

Primary outcomes

1

Description
Subjects under study are examined for the presence of hair loss in the target area (alopecia of the head area) based on the extent of loss (in cm2) and they are given a score from 0 to 10. The area of ​​the lesion below 10 square centimeters is determined and at the end of every month after the visit by a specialist doctor, hairy and terminal regrowth (Based on its extent is checked by examination, measurement (counting the number of hairs visually) and comparison with photography, as well as by surveying the patient.
Timepoint
Visit doctor monthly
Method of measurement
Physician examination and survey by questionnaire

Secondary outcomes

1

Description
Subjects under study are examined for the presence of hair loss in the target area (alopecia of the head area) based on the extent of loss (in cm2) and they are given a score from 0 to 10. The area of ​​the lesion below 10 square centimeters is determined and at the end of every month after the visit by a specialist doctor, hairy and terminal regrowth (Based on its extent is checked by examination, measurement (counting the number of hairs visually) and comparison with photography, as well as by surveying the patient.
Timepoint
Monthly for 3 months
Method of measurement
Visit by doctor and survey by questionnaire

Intervention groups

1

Description
IMen treated with minoxidil and herbal cream prepared daily and checked up by a doctor monthly- Women with alopecia areata (AA) who are treated with minoxidil and herbal cream prepared daily and checked-up by a doctor monthly
Category
Treatment - Drugs

2

Description
- Men with alopecia areata (AA) treated with minoxidil daily and triamcinolone cream and checked-up by a doctor monthly (control group).- Men with alopecia areata (AA) who are treated with minoxidil and placebo (cream without ingredients) daily and checked-up by a doctor monthly.- Women with alopecia areata (AA) treated with minoxidil daily and triamcinolone cream and checked-up by a doctor monthly (control group).- Women with alopecia areata (AA) who are treated with minoxidil and placebo (cream without ingredients) daily and checked-up by a physician monthly
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Elahe Aleebrahim Dehkordi
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 38 1334 6692
Fax
+98 38 1333 0709
Email
elahe.aleebrahim@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raisi
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 38 3333 6692
Email
rafieian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
محمود رفیعیان
Position
استاد
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 1334 6692
Fax
+98 38 1333 0709
Email
rafieian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahmmod Rafieian Kopaye
Position
استاد
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahrekord - Kashani Street - Shahrekord Univercity of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 38 1334 6692
Fax
+98 38 1333 0709
Email
rafieian@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahmoud Rafieian
Position
استاد
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 38 3335 1031
Email
rafieian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The project needs to complete.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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