Evaluation of Gel Formulation of Trigonella foenum-graceum Seeds on prevention of trichoptilosis in randomized placebo controlled Clinical Trial
Design
The total volume of the sample is 60 persons, which half of them is in the control and half of them is in the drug recipient group. The selection of the patients associated with the study will do by a dermatologist . The study is done in two- blind . People should not have any hair-related illnesses, including metabolic diseases, etc. Use of any hair products during treatment Should be under the supervision a dermatologist.
Settings and conduct
The study does under the supervision of a dermatologist at touba medical center . The randomized coded products are given to patients.
Participants/Inclusion and exclusion criteria
Patients by the age ranging 20 and 50 years should not have any hair-related illnesses including metabolic diseases, etc.
Intervention groups
The study consists of two groups of placebo and drug recipients .The intervention group received a medicinal gel containing the extract and the placebo or control group received an extract-free gel. The gels were rubbed daily by the individual to the entire hair and not allowed to be showered for 12 hours.
Main outcome variables
Checking of Improvement in Patients with trichoptilosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130911014630N4
Registration date:2018-07-16, 1397/04/25
Registration timing:retrospective
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Mohammad Azadbakht
Name of organization / entity
Mazandaran University of Medical Scinecee
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3728
Email address
mazadbakht@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Gel Formulation of Trigonella foenum-graceum Seed on prevention of trichoptilosis in randomized placebo controlled Clinical Trial
Public title
Evaluation of Gel Formulation of Trigonella foenum-graceum Seed on prevention of trichoptilosis in randomized placebo controlled Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Age 20-50
Man or woman
Selection of patients without prior knowledge and based on their referral to a specialist physician
The patient has an impairment trichoptilosis
The patient has a disorder of personal satisfaction with the use of the product
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, dermatologist, and dermatologist, as well as the placebo or drug product, have no information about the product and the products have been pre - determined and randomly assigned to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Mazandaran University Of Medical Sciences
Street address
Mazandaran University of Medical Sciences - Sari
City
Sari
Province
Mazandaran
Postal code
-
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.MAZUMS.REC.1396.2909
Health conditions studied
1
Description of health condition studied
Trichoptilosis
ICD-10 code
L67.8
ICD-10 code description
Other hair colour and Hair shaft abnormalities
Primary outcomes
1
Description
Trichoptilosis
Timepoint
At least 2 times in week along 2 month
Method of measurement
Questionnaire
Secondary outcomes
1
Description
calvities
Timepoint
At least 2 times in week along 2 month
Method of measurement
Questinnaire
Intervention groups
1
Description
Intervention group: The gel contains 5 grams extract of seeds of fenugreek used Twice daily , so that the whole hair should be covered . Do not shave 12 hours after use .To this end, 30 patients are selected according to the conditions of entry.They are given the drug gel formulation containing fenugreek seed extract for two months under the supervision of a dermatologist and in collaboration with the presenter.Herbal gel contains 5% fenugreek seed extract.To prepare 100 cc of gel, 0.02 grams of propyl paraben, 0.18 grams of methyl paraben, 1 gram of carbapl 980, 5 milliliters of glycerin, Small amount of 1% NaOH solutionn and up to 100 cc of distilled water, UP is used. It is expected that the extract of Fenugreek seed with its effect on the cuticle structure of the hair will increase its strength and reduce the bulging of the ends of hair shafts. This gel was made in the lab of the Mazandaran -Sari Pharmaceutical Faculty.
Category
Prevention
2
Description
Control group: The placebo gel contains all the ingredients of the drug gel except for the fenugreek seed extract.The method of use is the same as druged gel. It is used twice daily and Do not shave 12 hours after use.To this end, 30 patients are selected according to the conditions of entry.They are given the placebo gel formulation for two months under the supervision of a dermatologist and in collaboration with the presenter.It is expected that this gel does not have a significant effect, unlike the druged gel.This gel was made at the laboratory of the Mazandaran -Sari Pharmaceutical Faculty.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba Medical Center - Mazandaran University of Medical Science
Full name of responsible person
Dr. Mohammad Azadbakht - Dr.Ghasem Rahmatpour Rokni
Street address
Tuba Medical Center,Farah Abad Square ,Khazar Boulevard , Sari , Mazandaran ,Iran
City
Sari
Province
Mazandaran
Postal code
-
Email
Azadbakhtm@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Science- Sari - Mazandaran - Iran
Full name of responsible person
Dr.Mohammad Azadbkht
Street address
Pharmacy College - Payambar Azam Medicinal Complex - Sari - Mazandaran - Iran
City
Sari
Province
Mazandaran
Postal code
-
Email
Azadbakhtm@Hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Science- Sari - Mazandaran - Iran
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
Mazandaran University of Medicinal Science-Sari- Iran
Full name of responsible person
Majid Hajizadeh
Position
Pharmacy Student of Pharmacy College
Latest degree
A Level or less
Other areas of specialty/work
Street address
Pharmacy College - Payambar Azam Medicinal Complex - Sari - Mazandaran - Iran
City
Sari
Province
Mazandaran
Postal code
-
Phone
00
Fax
Email
Majidhajizadeh_72@Yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science-Sari
Full name of responsible person
Dr. Mohammad Azadbakht
Position
Pharmacognosy Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy College - Payambar Azam Medicinal Complex- Sari -Mazandaran -Iran
City
Sari
Province
Mazandaran
Postal code
-
Phone
00
Fax
Email
Mazadbakht@Mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran Universy of Medicinal Science-Sari
Full name of responsible person
Majid Hajizadeh
Position
Pharmacy Student Of Pharmacy College -Sari
Latest degree
A Level or less
Other areas of specialty/work
Street address
Payambar Azam Medicinal Complex-Pharmacy College - Sari
City
Sari
Province
Mazandaran
Postal code
-
Phone
+98 935 183 2770
Fax
Email
Majidhajizadeh_72@Yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Results from clinical trials
When the data will become available and for how long
Start access after printing the article
To whom data/document is available
Access for scholars working in academic institutions
Under which criteria data/document could be used
Use of results is allowed only by mentioning its source
From where data/document is obtainable
azadbakhtm@hotmail.com
What processes are involved for a request to access data/document