Study of The Effect of (Thymbra Spicata) plant on Blood Lipids Profile reduction in Human.
Design
This study is a nonblinded clinical trial. The study population will be included all patients with hyperlipidemia who refer to the office of one of the doctors in Kermanshah.104 eligible patients will be selected conveniently and randomly assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in a private medical office in the city of Kermanshah, is a non-blinded one. At the beginning of the study, 10 ccs of blood samples were taken from the patients, and then the lipid profile level of them will be measured using a spectrophotometric method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with a cholesterol level greater than 220 and triglycerides greater than 200 mg / dL
Exclusion criteria: Patients with metabolic diseases such as diabetes;
Taking any other antihyperlipidemic medication by the patient
Intervention groups
the intervention group in addition to atorvastatin will receive Thymbra Spicata plant daily in packaged leptons as herbal tea.
The control group only will receive atorvastatin daily.
Main outcome variables
Blood Lipids
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N151
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of (Thymbra Spicata) plant on Blood Lipids Profile reduction in Human.
Public title
The Effect of (Thymbra Spicata) plant on Blood Lipids Profile reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with a cholesterol level greater than 220 and triglycerides greater than 200 mg / dL
Exclusion criteria:
Patients with metabolic diseases such as diabetes
Taking any other antihyperlipidemic medication by the patient
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 52. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
ir.kums.rec.1399.175
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified
Primary outcomes
1
Description
Blood Lipids
Timepoint
Beginning of study and end of study (2 months later)
Method of measurement
laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in addition to atorvastatin will receive Thymbra Spicata plant daily in packaged leptons as herbal tea.
Category
Treatment - Drugs
2
Description
The control group only will receive atorvastatin daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal clinic
Full name of responsible person
Mohammad Saber Azizi
Street address
Ejlaliyeh building, Shahrdari parking
City
Kermanshah
Province
Kermanshah
Postal code
6714813142
Phone
+98 83 3725 6731
Email
www.mohamadsaberazizi.1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Saber Azizi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
www.mohamadsaberazizi.1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amir Kiani
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Toxicology
Street address
School of Pharmacy, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
www.amir1kiani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Saber Azizi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
www.mohamadsaberazizi.1994@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe