Formulation and evaluation of topical product containing Myrtus communis L. and Phyllanthus emblica L . on hair loss based on iranian traditional medicine
The aim of this study is formulation and evaluation of topical product of myrtacea and phyllanthus on hair loss in human
Design
This study is randomized controlled pilot study to evaluate the effect of myrthus and pyllanthus on hair loss
Settings and conduct
The initial number of participants is 10 in each group which considering 10% dropout rate will be 20 in total and volunteers will be randomly assigned to the intervention and placebo groups
Participants/Inclusion and exclusion criteria
Woman participant age between 18 to 60 with complain of hair loss more than 6 months and non-entry criteria including woman with ovarian polycystic syndrome user of steroid and androgenic drugs hypothyroidism any hypersensitivity to any of ingredients of this product and G6PD deficiency
Intervention groups
Intervention group will use a traditional medicine gel containing leaves of myrthus and pyllanthus twice a day for 4 to 6 to 8 weeks
and The control group will use a plain gel without herbal extract as a placebo, 15 drops, twice a day, for 6 to 8 weeks.
Main outcome variables
Rate of hair loss based on Likert'; hair loss base on comb test; patient satisfaction with treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240702062307N1
Registration date:2025-03-04, 1403/12/14
Registration timing:registered_while_recruiting
Last update:2025-03-04, 1403/12/14
Update count:0
Registration date
2025-03-04, 1403/12/14
Registrant information
Name
Armita Sabahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8842 2411
Email address
sabahi.armita@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-16, 1403/11/28
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and evaluation of topical product containing Myrtus communis L. and Phyllanthus emblica L . on hair loss based on iranian traditional medicine
Public title
Formulation and evaluation of topical product containing Myrtus communis L. and Phyllanthus emblica L . on hair loss based on iranian traditional medicine
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Woman age between 18 to 60
Hair loss complain more than 6 months
Exclusion criteria:
Any hypersensitivity to ingredients of gel
Steroids users
Any cancer
History of hair transplantation
Any deficient in g6pd enzyme
Polycystic ovarian syndrome
Androgenic drug user
Hypothyroidsm
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
To divide people into two groups of 10 people, you can first randomly assign people from 1 to 20 numbers, then divide them into two groups using SAS 9.1 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researcher
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Islamic Azad Medical Sciences, University of Pharmacy
Street address
Yakhchal street, Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.IAU.PS.REC.1403.160
Health conditions studied
1
Description of health condition studied
Telogen effluvium
ICD-10 code
L65.0
ICD-10 code description
Telogen effluvium
Primary outcomes
1
Description
Satisfaction with hair loss, increased hair growth, and hair quality
Timepoint
Before the intervention, the first and fourth weeks after the start of the intervention
Method of measurement
By examining and questioning the patient and completing the Hamilton Hair Loss Questionnaire, the questionnaire assesses the level of satisfaction with hair loss before and after the intervention, as well as the level of satisfaction with the private status of hair loss, increased hair growth, and quality based on a five-point scale from very dissatisfied with a score of zero to very satisfied with a score of 5.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The intervention group included 10 participants who received a placebo, which contained a simple gel without extract, administered twice daily, 15 drops of the desired gel each time, for 0, 4,8 weeks
Category
Treatment - Other
2
Description
Control group: The control group will use a simple gel without herbal extract as a placebo, 15 drops, twice a day, for 0, 4, and 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Institution of Traditional Medicine
Full name of responsible person
Ghazaleh Heydari Rad
Street address
Shahid Beheshti Institution of Traditional Medicine, Tavanir St., Vali Asr street
City
Tehran
Province
Tehran
Postal code
1996836111
Phone
+98 21 8877 3521
Email
dr.ghazalrad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Amirhossein Abdul Ghaffari
Street address
Yakhchal street, Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2263 3986
Email
maryamjahandideh2009@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university
Proportion provided by this source
30
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
Islamic Azad University
Full name of responsible person
Armita Sabahi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Islamic Azad University, Yakhchal street, Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 8842 2411
Email
sabahi.armita@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Armita Sabahi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Islamic Azad University, Yakhchal street, Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 22633986
Email
sabahi.armita@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aarmita Sabahi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Islamic Azad University, Yakhchal street, Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2263 3986
Email
sabahi.armita@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