Evaluation of the effect of oral product containing Amla fruit (Phyllanthus emblica L.) on women’s androgenic alopecia: a Randomized Controlled Clinical Trial.
Evaluation of the effect of an oral product containing Amla fruit on women's androgenic alopecia
Design
A paralleled-triple-blinded randomized clinical trial with 30 cases in each two study groups
Settings and conduct
This study will be conducted on eligible patients referred to Dermatology and Leprosy Research and Training Research Center. After finding eligible cases, explaining the study goals, and taking a written consent form, all participants will be assigned to two study groups, intervention, and control, using a random allocation method. In the following, after registering subject identifications, similar pockets containing the drug or placebo will be given to each group. Researchers, volunteers, outcome assessors, and statistical data analysts do not have any information about drugs and placebo groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women aged 18 to 60 years old, type 1 to 2 hair loss according to the Hamilton Hair Loss Criterion that has lasted more than six months, and patient's consent to participate in the study; Exclusion criteria: records of using any typical products to prevent hair loss or stimulate hair growth, using 5 α reductase inhibitors, using anti-androgenic drugs, systemic steroid treatments, any active diseases in the head including scalp infection, any records of acute illness, history of any cancer or autoimmune diseases, undertaking hair transplantation, having chronic diabetes, hypothyroidism, polycystic ovary syndrome, pregnancy, and lactation.
Intervention groups
Each eligible patient will take 30 ml (10 ml syrup after each meal) of medicine or placebo daily for 12 weeks.
Main outcome variables
Number of hair strands; Terminal hairs to Volos; Ratio of anagen to telogen hair; Physician satisfaction with treatment; Patient satisfaction of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201010048979N2
Registration date:2021-10-27, 1400/08/05
Registration timing:registered_while_recruiting
Last update:2021-10-27, 1400/08/05
Update count:1
Registration date
2021-10-27, 1400/08/05
Registrant information
Name
Marzieh َAkhbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3656
Email address
akhbari-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-16, 1400/07/24
Expected recruitment end date
2022-03-15, 1400/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral product containing Amla fruit (Phyllanthus emblica L.) on women’s androgenic alopecia: a Randomized Controlled Clinical Trial.
Public title
The effect of oral product containing amla fruit on women’s androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 60 years old
Type 1 to 2 hair loss according to the Hamilton Hair Loss Criterion that has lasted more than 6 months
Patient consent approval to participate in the study
Exclusion criteria:
Records of using any typical products to prevent hair loss or stimulate hair growth in the past 2 months
Utilizing 5 α reductase inhibitors in the past 2 months
Records of taking anti-androgenic drugs in the past 2 months
Records of systemically taken steroids for more than 14 days in the past 2 months
Any active diseases in the head including scalp infection in the past 6 months
Records of any types of cancer or autoimmune diseases
Any records of hair transplantation
Pregnancy and lactation
The history of underlying diseases of diabetes, hypothyroidism, polycystic ovary syndrome
The history of acute illness in the last 2 months
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The study group will be randomly divided into two groups of medicine and placebo. Due to patients' gradual referral and maintaining balance in groups, individuals are randomly selected by permuted block randomization with quadruple blocks. Thus, according to the table of random numbers, four samples of one of the blocks with the sequence; BAAB, BABA, BBAA AABB, BAAB, ABAB are selected. Letter A means assigning a person to the intervention group, and letter B means assigning a person to the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The medicine and the placebo are the same in appearance and packaging. They can be distinguished only by the unique codes inserted by the pharmacist on the medicine bottle's label. The patient and the researcher prescribing and analyzing the data are not aware of the meaning of the codes. The study results are also reviewed by a researcher who is unaware of the grouping and is blind to the groups and the type of drug.
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
1th Floor, Medicine School, Poursina St, Qods St, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.414
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Number of hair strands
Timepoint
Before intervention, 12 weeks after the intervention
Method of measurement
Trichoscan
2
Description
Terminal hair to Volos hair
Timepoint
Before intervention, 12 weeks after the intervention
Method of measurement
Trichoscan
3
Description
Ratio of anagen to telogen hair
Timepoint
Before intervention, 12 weeks after the intervention
Method of measurement
Trichoscan
4
Description
Physician satisfaction with treatment
Timepoint
Before intervention, 6 and 12 weeks after the intervention
Method of measurement
questionnaire
5
Description
Patient satisfaction with treatment
Timepoint
Before intervention, 6 and 12 weeks after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each eligible patient will take 30 cc of medication (10 cc of amla syrup after each meal) daily for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Each eligible patient will take 30 cc (10 cc syrup after each meal) of placebo daily for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز آموزش و پژوهش بیماری های پوست و جذام
Full name of responsible person
Marzieh Akhbari
Street address
Center for Research and Training in Skin Diseases and Leprosy, N.79, Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
mentalhealh8981@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
leila Shirbeigi
Street address
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 3656
Email
l.shirbeigi@yahoo.com
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
Marzieh Akhbari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 3656
Email
mentalhealth8981@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Shirbeigi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 3656
Email
l.shirbeigi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Akhbari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 3656
Email
mentalhealth8981@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data from primary and secondary outcomes of patients will be available on supplementary files of published paper
When the data will become available and for how long
Available after publishing results
To whom data/document is available
All academic people
Under which criteria data/document could be used
It has not been made a decision yet.
From where data/document is obtainable
The person responsible for general accountability
What processes are involved for a request to access data/document