Comparing the efficacy of topical herbal preparation and minoxidil on androgenic alopecia in the male patients referred to Imam Reza hospital dermatology clinic
Design
Double-blind clinical trial, with parallel groups, randomized, phase I on 60 patients, with a 4-block randomization method will be randomized
Settings and conduct
This double-blind clinical trial will be done in Mashhad Imam Reza hospital and patients with androgenic alopecia will be randomly divided into groups receiving topical herbal preparation (containing extracts of Adiantum capillus-veneris 1%, Phyllanthus emblica 5%, Centella asitica 0.5%, Ruta graveolense 0.5%) and topical minoxidil 5%. Trichoscopy and self-assessment parameters by patients will be evaluated at baseline and end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male patient between 18-45 y/o
Androgenic alopecia grade 3-6 base on hamilton-norwood scale system
Patient satisfaction
Exclusion criteria:
Diabetes , thyroide dysfunction and other endocrine disease
Using supplement including iron & zinc
Renal disease,malnutrition,iron deficiency anemia, systemic disease such as lupus, other cause of alopecia including areata or cicatricial alopecia,
Using Medication can cause hair loss including antihypertensive drug , NSAID
History of dermatologic or systemic malignancy
Psychologic disorders
Drug or alcohole abuse
History of finastride treatment in past 6 month
Intervention groups
Group 1 (control): will receive standard treatment: topical minoxidil
Group 2 (intervention): will recieve topical herbal preparation
Main outcome variables
Hair count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220626055283N1
Registration date:2022-11-30, 1401/09/09
Registration timing:registered_while_recruiting
Last update:2022-11-30, 1401/09/09
Update count:0
Registration date
2022-11-30, 1401/09/09
Registrant information
Name
Mahdieh Toosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3723 6716
Email address
tousimh991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-11, 1401/08/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical herbal preparation with minoxidil in androgenic alopecia: double blind randomized clinical trial
Public title
Efficacy of herbal solution in androgenic alopecia treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male patient between 18-45 years old with androgenic alopecia
Patient satisfaction
Exclusion criteria:
Endocrine disorder
Using zinc and iron supplement
Renal disease
Malnutrition and iron deficiency anemia
Thyroid disorder
Systemic disorder such as lupus
Other causes of alopecia like alopecia areata and scar alopecias
Using drugs lead to alopecia like anti-hypertensive agents or NSAIDs
History of dermatologic or systemic malignancy
Psychiatric disorders
Consumption of alcohol
History of consumption of finasteride within 6 months ago
Age
From 18 years old to 45 years old
Gender
Male
Phase
1
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to topical herbal preparation or topical minoxidil groups, by block randomization with a block size of 4. In each block, patients of each group will exist. The order of blocks will be determined randomly in topical herbal preparation or topical minoxidil groups and subjects will be allocated sequentially with the order of admitting. The random allocation rule method was used for the determination of sequences. Use non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients receive drugs (intervention or control groups) in closed pockets which are coded and patients are not aware of their contents. Coding will be done by one of the colleagues of the study and the investigator physician will be blind for the type of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Scineces (Ghorashi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.MUMS.fm.REC.1396.602
Health conditions studied
1
Description of health condition studied
Male androgenic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Hair count
Timepoint
Evaluation of hair count with trichoscopy in 0, 8, 16 , 24 weeks of trial
Method of measurement
Efficacy of herbal solution (Adiantum Capillus-veneris, Centella asitica, Rutagraveolense, Emblica officinalis) on androgenic alopecia and examine hair count with trichoscopy
Fifth floor, Akbar hospital, Kaveh Boulevard, Javan Square, Mahhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
saeidiniaa971@mums.ac.ir
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
There is no more data
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of clinical trial in analysis will be published in an article after blinding patients' data
When the data will become available and for how long
Unlimited from publishing
To whom data/document is available
Researchers in medical universities
Under which criteria data/document could be used
Data are specific for this study and is not reusable
From where data/document is obtainable
Request by email to the corresponding author recorded in this registry
Dr. Bita Kiafar
Email: Kiafarb@mums.ac.ir
Tel: +985138022031
Address: Dermatology department, Imam Reza hospital, Imam Reza hospital square, Avecina street, Imam Reza hospital square, Mashhad
What processes are involved for a request to access data/document
Sending a formal request with details of the needed information to the email of the person responsible for scientific inquiries. Then it will be responded to after one week by the person responsible for scientific inquiries.