This study is a randomized double blind , controlled with drug and placebo , single- center , parallel clinical trial on 105 overweight and obese patients aged 18 to 50 who have any metabolic disease and don’t use nutritional supplement .Their baseline weight , BMI and metabolic profiles will be checked and devided to one of the groups received a capsules cumin, venustat capsules or placebo capsules three times daily for 8 weeks randomly. Patients don’t change in Physical Activity and get food that cheked with standardized questionnaires . Finally the weight changes , metabolic profile , liver enzymes ,thyroid hormones , inflammatory markers and antioxidant parameters is measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014043012438N8
Registration date:2014-05-20, 1393/02/30
Registration timing:prospective
Last update:
Update count:1
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of capsule contain cumin essential oil on weight and metabolic profile of obese and over weight patients and its comparison with venustat
Public title
The effect of cumin pearl on treatment of obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18-50 years old.BMI>25
exclusion criteria: metabolic disorders.nutritional supplements.pregnancy.lactation.thyroid and parathyroid disease.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
633/1/5/29/ب
Health conditions studied
1
Description of health condition studied
obesity and over weight
ICD-10 code
E66
ICD-10 code description
Obesity
Primary outcomes
1
Description
weight
Timepoint
baseline and end of study
Method of measurement
scale
2
Description
metabolic profile
Timepoint
baseline and end of study
Method of measurement
blood test
3
Description
liver enzymes
Timepoint
baseline and end of study
Method of measurement
blood test
4
Description
total anti oxidant
Timepoint
baseline and end of study
Method of measurement
blood test
5
Description
Thyroid hormones
Timepoint
baseline and end of study
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:cumin essential oil capsule 3 times a day for 8 weeks
Category
Treatment - Drugs
2
Description
drug control:venustat capsule 3 times a day for 8 weeks
Category
Treatment - Drugs
3
Description
placebo control:placebo capsule 3 times a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Zatollah Asemi
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)