Protocol summary
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Study aim
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Effect of topical plant solution on prevention and treatment of androgenic hair loss and comparison with minoxidil 5%
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Design
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This study is done on male patients with androgenic hair loss. The patients will be selected by volunteers attending Dermatology department of Sina Hospital and eligible individuals will be selected among them. The participants will be randomly allocated (using random number tables) to two groups, plant solution or minoxidil. Sample size will be 40 patients.
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Settings and conduct
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This study will be conducted on patients aged 18 to 50 years old with mild to moderate androgenic hair loss in the department of Sina Hospital. They will be randomly divided into 2 groups, and the patient and doctor will be unaware of the type of received treatment . Both groups will use the same package of medications.
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Participants/Inclusion and exclusion criteria
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Entry requirements include 18 to 50-year-olds who are clinically diagnosed with Hamilton's criteria for grade 3 to 5 androgenetic alopecia, have a normal general health condition and have written consent.
Exclusion criteria include the use of any local herbal remedy for hair loss in the past 3 months, chemotherapy and anti-inflammatory drugs and 5-alfa reductase drugs in the past 1 year, systemic steroid in past 14 days, uncontrolled hypertension, any chronic inflammation or infection in Scalp, people with hormonal diseases such as thyroid disorders, diabetes, liver disease, kidney, cancer, people without written consent and smokers.
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Intervention groups
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Intervention group: Use of minoxidil solution in the morning and herbal solution at night, every day in hair loss areas for 3 to 6 months
Control group: Use minoxidil solution every day in hair loss areas for 3 to 6 months
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Main outcome variables
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Number of hair; hair thickness;
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181103041541N1
Registration date:
2019-02-16, 1397/11/27
Registration timing:
registered_while_recruiting
Last update:
2019-07-15, 1398/04/24
Update count:
1
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Registration date
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2019-02-16, 1397/11/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-28, 1397/09/07
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Expected recruitment end date
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2019-07-23, 1398/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison with Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study
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Public title
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Effect of topical plant solution on male hair loss
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men 18 to 50 years old
Written consent
General health status is normal
Hamilton's 2 to 5 degree hair loss
Exclusion criteria:
Use of any topical product for hair loss in the last 3 months
Use of chemotherapy drugs and anti-inflammatory drugs and 5-alfa reductase drugs in the past 1 year
Uncontrolled hypertension
Any chronic inflammation or infection in the scalp
Hormonal diseases such as thyroid disorders, diabetes and ...
Smokers
Liver and kidney disease
No written consent
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Age
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From 18 years old to 50 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A computer-generated list of random numbers was used.
The randomization sequence was created using Stata 9.0 statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Both groups of patients use the same package.
The Doctor and the patient are unaware of the type of used drug .
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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مرکز ثبت کارآزمایی بالینی آمریکا
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Secondary trial Id
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NCT03753113
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Registration date
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2018-11-26, 1397/09/05
Ethics committees
1
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Ethics committee
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Approval date
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2018-08-06, 1397/05/15
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Ethics committee reference number
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IR.TBZMED.REC.1397.384
Health conditions studied
1
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Description of health condition studied
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Androgenic Alopecia
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ICD-10 code
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L64
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ICD-10 code description
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Androgenic alopecia
Primary outcomes
1
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Description
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Number of hair
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Timepoint
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Before intervention, 2 months later, 4 or 6 months later
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Method of measurement
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Global photograph of a patient
2
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Description
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Hair thickness
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Timepoint
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Before intervention, 2 months later, 4 or 6 months later
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Method of measurement
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Fotofinder trichoscale
Intervention groups
1
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Description
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Intervention group: Use of minoxidil solution in the morning and herbal solution at night, every day in hair loss areas for 3 to 6 months
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Category
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Treatment - Drugs
2
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Description
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Control group: Use minoxidil solution every day in hair loss areas for 3 to 6 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available