Effect of cuminum cyminuim on metabolic syndrome indices in women of reproductive age referring to comprehensive health services centers of Rafsanjan, 1397
Design
Clinical trial with control group،Triple Blind, Simple Randomization
Settings and conduct
A triple controlled clinical trial with placebo.In this trial, the drug and placebo packs are coded by the pharmacist.As a result, patient, researcher, and data analyst are unaware of the nature of each individual case.Samples will be selected among women of reproductive age (aged 15-45) who are referred to the health centers of Rafsanjan.Then, based on entry criteria and simple random allocation, the two groups will receive 500 mg of cumin every 12 hours and placebo.
Participants/Inclusion and exclusion criteria
Inclusion measures:
Women aged 18-45
Unwillingness to be pregnant
Lack of chronic disease (cardiovascular disease, history of myocardial infarction, cerebrovascular accident, kidney and liver disease, cancer, mental illness)
Not having weight loss regimens
Not pregnancy
Not smoking and alcohol
Non-use of drugs
Not taking warfarin and heparin
Exclusion measures:
Sensitization to drug
No drug intake for two consecutive days
Pregnancy during the study period
Unwillingness to continue cooperation
Having one of the diseases listed during the study period
Participate in sports classes during the study
Intervention groups
Intervention group:The intervention group is asked to take one capsule of 500 mg cuminum cyminium every 12 hours with a glass of water after a meal.
control group:The control group is asked to take a placebo capsule every 12 hours with a glass of water after a meal.
Main outcome variables
Mean concentration of fasting glucose
Triglyceride
High Density Lipoprotein
Blood Pressure
Waist size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026971N7
Registration date:2020-02-08, 1398/11/19
Registration timing:retrospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
2019-01-20, 1397/10/30
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-09-21, 1398/06/30
Scientific title
The effect of cuminum cyminum on metabolic syndrome indicators in reproductive age women
Public title
Effect of Cuminum cyminum on Metabolic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 15-45
Use of contraceptive methods
Not pregnant
Having three of the five criteria for metabolic syndrome
Exclusion criteria:
Drug sensitivity
No drug intake for two consecutive days
Unwillingness to continue cooperation
Participate in sports classes
chronic disease
Weight loss diets
Alcoholism, tobacco and drugs abuse
Use of warfarin and heparin
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using Random Number Table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this trial, drug and placebo packs are coded by the pharmacist.As a result, the patient, the researcher and the data analyst are unaware of the nature of each packet
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Science
Street address
Central department of Rafsanjan University Medical Science،immam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2019-01-09, 1397/10/19
Ethics committee reference number
IR.RUMS.REC.1397.181
Health conditions studied
1
Description of health condition studied
Metabolic syndrom
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean concentration of fasting plasma glucose ، Triglyceride ،High Density Lipoprotein، Blood Pressure،Waist
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The mean fasting plasma glucose concentration is based on the laboratory's response.Triglyceride is based on the laboratory's response. High Density Lipoprotein is a based on the laboratory's response.Hypertension is using a blood pressure monitor,The waist is measured using non-elastic bandwidth meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 500-mg capsule made from cumin every 12 hours will be taken with a glass of water after eating for 8 weeks, whicht was made by the Iranian faculty of Medical Sciences College of Kerman Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: A placebo capsule containing "starch" that takes all the same appearance as the cumin capsule, will take one tablet every 8 hours for 12 hours.whicht was made by the Iranian faculty of Medical Sciences College of Kerman Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز بهداشتی درمانی شماره 1
Full name of responsible person
شیرین محمودی
Street address
Healt Center No.1،Imam khomeini Ave.Qods Sq
City
Rafsanjan
Province
Kerman
Postal code
7717653548
Phone
+98 34 3428 2075
Email
ava.man623@yahoo.com
2
Recruitment center
Name of recruitment center
مرکز بهداشتی درمانی شماره 2
Full name of responsible person
شیرین محمودی
Street address
مرکز بهداشتی درمانی شماره 2،کوچه 41،خیابان 15 خرداد
City
Rafsanjan
Province
Kerman
Postal code
771433579
Phone
+98 34 3423 0887
Email
amiirsh@gmail.com
3
Recruitment center
Name of recruitment center
مرکز بهداشتی درمانی شماره 3
Full name of responsible person
شیرین محمودی
Street address
مرکزبهداشتی درمانی شماره3،روبه روی بانک مرکزی،خیابان شریعتی غربی
City
Rafsanjan
Province
Kerman
Postal code
7713654887
Phone
+98 34 3425 9164
Email
sangielahe@yahoo.com
4
Recruitment center
Name of recruitment center
مرکز بهداشتی درمانی شماره 4
Full name of responsible person
شیرین محمودی
Street address
Healt center No.4،Amir Kabir St،in front the childrins park
City
Rafsanjan
Province
Kerman
Postal code
7718663316
Phone
+98 34 3432 5911
Email
alipourzohre@yahoo.com
5
Recruitment center
Name of recruitment center
Healt center No.5
Full name of responsible person
Shirin Mahmoodi
Street address
Healt center No.5،Kargar St
City
Rafsanjan
Province
Kerman
Postal code
7716676788
Phone
+98 34 3425 3035
Email
marzeyeloripoor@yahoo.com
6
Recruitment center
Name of recruitment center
Healt center No.6
Full name of responsible person
Shirin Mahmoodi
Street address
Healt center No.6،Mostafa Khomeini Street
City
Rafsanjan
Province
Kerman
Postal code
7714645553
Phone
+98 34 3422 3090
Email
shojaeibehnazz@gmail.com
7
Recruitment center
Name of recruitment center
Healt center No.7
Full name of responsible person
shirin Mahmoodi
Street address
Healt center No.7،Shahid Shafiei،Hojjat Bolvar،Shahrak Valfajr
City
Rafsanjan
Province
Kerman
Postal code
7717837899
Phone
+98 34 3435 3427
Email
mohebbimama@yahoo.com
8
Recruitment center
Name of recruitment center
Healt center no.8
Full name of responsible person
Shirin Mahmoodi
Street address
Healt center no.8،near Gaz station،Azadi Bolvar
City
rafsanjan
Province
Kerman
Postal code
7717964849
Phone
+98 34 3428 2075
Email
pormohammadali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Ali Shamsizadeh
Street address
Imam ali Bolvar.Research &Technology،central Office of Rafsanjan university of Medical sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Fax
+98 34 3428 0097
Email
alishamsy@gmail.com
Web page address
http://vcrt.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery،Nursing Street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 5900
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
marzeyeh Loripoor
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
faculty of Nursing and midwifery،Nursing street
City
rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Facuity of Nursing and Midwifiry،Nursing street
City
rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.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