Local Effect of Cuttlebone Lipogel on Sub-Cutaneous Fat Accumulation in women
Design
The study group consisted of 30 women. A placebo controlled clinical trial, with parallel groups, double-blind, randomized. the first phase is on 30 female patients. Excel software rand function was used for randomization.
Settings and conduct
In human study, questionnaire method and is used. Also, this study is performed as a randomized, double-blind placebo controlled. therefore: 30 patients were randomly selected by a physician and divided into 2 groups of 15, one group will receive lipogel containing sea floor extract and the other group will receive a placebo.patients and the researcher are blined. The duration of the study is 12 weeks. This study was conducted at Mazandaran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: includes obesity around the abdomen and excess fat on the sides and abdomen more than 80 cm and BMI more than 25. Exclusion criteria: People under 18 and over 50, pregnant women, people with systemic diseases leading to obesity, people taking certain obesity-causing drugs and people who are allergic to plant and seafood products.
Intervention groups
The 30 patients in the study were divided into 2 groups of 15, one of which would receive lipogels containing the extract (as the test group) and the other group would receive a placebo.
Main outcome variables
Waist size ,Waist-Hip ratio(WHR), blood serum lipid profiles including low and high density lipoproteins(LDL& HDL), cholesterol, Triglyceride.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130911014630N10
Registration date:2022-05-13, 1401/02/23
Registration timing:registered_while_recruiting
Last update:2022-05-13, 1401/02/23
Update count:0
Registration date
2022-05-13, 1401/02/23
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
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2022-05-23, 1401/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Local Effect of Cuttlebone Lipogel on Sub-Cutaneous Fat Accumulation in women; A Randomized, Placebo-Controlled, Double-Blinded Study
Public title
Evaluation of Local Effect of Cuttlebone Lipogel on Sub-Cutaneous Fat Accumulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
obese women referring to a specialist
Age range 18 to 50 years
patient has a disorder of subcutaneous fat accumulation
patient has a personal dissatisfaction with the use of the product.
Exclusion criteria:
People under 18 and over 50
pregnant women
people with systemic diseases leading to obesity
people taking certain obesity-causing drugs
people who are allergic to plant and seafood products
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Excel software was used for randomization. Using the Rand function in Excel software, random numbers are obtained and using these numbers, each person in the study is placed in drug or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this Study, patients and Data Analyzer have no information about the product that it is drug or placebo. the products have given pre - determined cods 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 Committee of Mazandaran University of Medical Sciences
Street address
Prophet Mohammad Medical Sciences Complex.Farahabad Street
City
Sari
Province
Mazandaran
Postal code
48188-69378
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.MAZUMS.REC.1398.571
Health conditions studied
1
Description of health condition studied
Sub-Cutaneous Fat Accumulation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Localized obesity or waist size
Timepoint
at baseline and after 12 week
Method of measurement
Tape meters
2
Description
Waist-Hip Ratio
Timepoint
at baseline and after 12 week
Method of measurement
Tape meters
3
Description
blood serum lipid profile including Triglycerides, cholesterol and Low and high density lipoproteins.
Timepoint
at baseline and after 12 week
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 individual received Cuttlebone Lipogel. At this stage, based on the recommended amounts of traditional medicine and taking into account the non-toxicity, the amount of Cuttlebone consumption per 100 grams of the gel base is 10 grams and the amount of lipogel consumption three times a day is about 5 grams for an area of 250cm2 (25 × 10 cm) from the person's abdomen will be considered. Duration of the intervention is 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: 15 patients were randomly selected and received placebo for 12 weeks, 3 times a day. 5 grams of the gel applys on 250 cm2 of abdomonal area. The placebo contains all the ingredients of the main medicine, but the active ingredient of the sea floor has been removed
Category
Placebo
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
48188-69378
Phone
+98 911 151 3032
Email
Azadbakhtm@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Pharmacy
Full name of responsible person
Dr Mohammad Azadbakht
Street address
Farah abad street
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 911 151 3032
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
Vice chancellor for research, Faculty of Pharmacy
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 Medical Sciences
Full name of responsible person
Mohammad Azadbakht
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
18 KM Kazarabad Road, The Campus of Mazandaran University of Medical Sciences and health services
City
Sari
Province
Mazandaran
Postal code
48188-69378
Phone
+98 15 1214 4052
Fax
Email
mazadbakht@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Akbari
Position
Student of Natural Medicinal and Marine CompoundsCollege -Sari
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam Medicinal Complex-Pharmacy College - Sari
City
Sari
Province
Mazandaran
Postal code
-
Phone
+98 912 851 8809
Fax
Email
f_akbari1987@Yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Akbari
Position
. Student of Natural Medicinal and Marine Compounds College -Sari
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam Medicinal Complex-Pharmacy College - Sari
City
Sari
Province
Mazandaran
Postal code
48188-69378
Phone
+98 912 851 8809
Fax
Email
f_akbari1987@Yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Results from clinical trials
When the data will become available and for how long
1400/12/10
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use of results is allowed only with the mention of the source and In order to expand the study