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Evaluation of the Effect of Topical Lotion of Myrtus communts and Phyllanthus emblica on the Androgenic Alopecia in Women: A Clinical Trial Study

Protocol summary

Study aim
The effect of Topical Lotion of Myrtus communts and Phyllanthus emblica on the Androgenic Alopecia in Women
Design
Randomized clinical trial including 3 interventional and 1 control groups, and it is triple-blinded. Phase 3 with 120 cases, randomly included in the study using "R software" by statistics specialist.
Settings and conduct
Through Ahmadieh and Khark Salamatkadeh and under the observation of dermatologist the patients enter the study, then precise assessment will be done in the derma lab of the" Center for Research and Training in skin disease and Leprosy". Statistics specialist allocated randomized codes by "R software" to study groups so patients, investigator and analyzer are blinded (triple blinded).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female Subjects (18-60) falling hair loss who are not menopause. and give a written informed consent Exclusion criteria: • History of allergic response/hypersensitivity to any ingredients and pharmaceutical products. • Medical history of thyroid disorder, diabetes mellitus, poly cystic ovary syndrome • Medical treatment for hair problems, consuming drugs (such as Minoxidil, Finasteride, Platelet rich plasma or Biotin),5 α-reductase inhibitors, corticosteroid therapy, antiandrogenic agents and laser therapy in the 2 months prior to the study • Any active scalp disease , cancer or autoimmune diseases, hair transplant, serious acute illness • Pregnancy or breast - feeding
Intervention groups
1) Myrtus communts and Phyllanthus emblica 2) Phyllanthus emblica 3) Myrtus communts 4) placebo
Main outcome variables
1.Trico scan assessment: Hair number; Hair density; Hair diameter; anagen - telogen ratio 2. Patient satisfaction assessment (5 Likert): before and after study in all groups. 3.physician satisfaction assessment (5Likert): before and after study about all patients in groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230808059082N1
Registration date: 2024-02-24, 1402/12/05
Registration timing: prospective

Last update: 2024-02-24, 1402/12/05
Update count: 0
Registration date
2024-02-24, 1402/12/05
Registrant information
Name
Farzaneh Maftoon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8806 1291
Email address
fmaftoon5@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical Lotion of Myrtus communts and Phyllanthus emblica on the Androgenic Alopecia in Women: A Clinical Trial Study
Public title
Effect of Lotion of Myrtus communts and Phyllanthus emblica on the Androgenic Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females in the pre-menopausal period complaining of hair loss Patient consent to participate and fill out the informed consent form.
Exclusion criteria:
History of allergic response/hypersensitivity to any ingredients and pharmaceutical products. History of thyroid disorder, diabetes mellitus, polycystic ovary syndrome Subjects under medical treatment for hair problems, consuming drugs (such as minoxidil, finasteride, platelet rich plasma or Biotin) and laser therapy in the 2 months prior to the study Subjects under medical treatment for hair problems with 5 α-reductase inhibitors. Subjects under medical treatment with antiandrogenic agents (such as spironolactone, cimetidine and cyproterone acetate) in the 2 months prior to the study Subjects consuming systemic corticosteroid therapy for more than 14 days in the 2 months prior to the study Any active scalp disease in the 6 months prior to the study Any history of cancer or autoimmune diseases History of hair transplant Pregnancy or Brest - feeding History of serious acute illness in the 2 months prior to the study
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly assigned treatments to the patients will be accomplished using R software by statistics specialist .Thus statistics specialist allocated randomized codes by "R software" to study groups so patients, investigator and analyzer are blinded(triple blinded).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding: Patients, researchers and analysts will not be informed of the random assignment of groups until the end of the study. Coding and also the pharmaceutical packaging for all groups is uniform, and the contents of the containers are similar in terms of consistency and color. At the end of the study, the desired code for grouping, which is inserted on the drug package, will be decoded to match the information and analyze the data.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Headquarters Building, Ghods street corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.054

Health conditions studied

1

Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia

Primary outcomes

1

Description
Hair count (number of hairs in 0.7 cm2)
Timepoint
Week 8, week 16
Method of measurement
Trichoscan method

2

Description
Hair density (number of hairs in cm2)
Timepoint
Week 8, week 16
Method of measurement
Trichoscan method

3

Description
Hair diameter
Timepoint
Week 8, week 16
Method of measurement
Trichoscan method

4

Description
ratio of anagen to telogen
Timepoint
week8, week16
Method of measurement
Trichoscan method

Secondary outcomes

1

Description
Dandruff
Timepoint
Before and after study (week1, week16)
Method of measurement
Patient view assessment (5 Likert)

2

Description
Greasy hair
Timepoint
Before and after study (week1, week16)
Method of measurement
Patient view assessment(5 Likert)

Intervention groups

1

Description
Intervention groups: 4 including group 1: Iranian traditional medicine lotion based on Mirtica, group 2: traditional medicine lotion based on Amla, group 3: herbal product lotion based on the combination of Mirtica and Amla, and finally group 4: placebo lotion.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahmadieh Salamatkadeh
Full name of responsible person
Farzaneh Maftoon
Street address
َAhmadieh salamtkadeh, Sarparast str.,Talaghani str.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
spm@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Headquarters Building of Tehran University of Medical science, Ghods street corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh Maftoon
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Ahmadieh salamtkadeh, Sarparast str.,Talaghani str.
City
Tehran
Province
Tehran
Postal code
1417613151َ
Phone
+98 912 326 2644
Email
fmaftoon5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh Maftoon
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Ahmadieh salamtkadeh, Sarparast str.,Talaghani str.
City
Tehran
Province
Tehran
Postal code
1417613151َ
Phone
+98 912 326 2644
Email
fmaftoon5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meysam Shirzad
Position
Scientific Member
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Ahmadieh salamtkadeh, Sarparast str.,Talaghani str.
City
Tehran
Province
Tehran
Postal code
1417613151َ
Phone
+98 912 317 1481
Fax
Email
shirzadmd@gmail.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
For ethical reasons
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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