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Effects of Melissa Officinalis L. on Lipid Profile in Patients with Hyperlipidemia

Protocol summary

Summary
Objectives, Design, Setting and conduct: The aim of this research is to determine the effects of Melissa Officinalis on lipid profile in Patients with Hyperlipidemia. This study is a randomized double‐blind placebo‐controlled clinical trial. The study conducted on 60 hyperlipidemic patients who were not in clinical range to taking other antihyperlipidemic agents. Major Inclusion and Exclusion criteria: Male and female aged 25 to 65 years with cholesterol levels 200 to 260 mg/dl who do not need to take of serum lipids lowering drugs were recruited randomly. The patients with diabetes, coronary vascular disease, renal, hepatic, hematological, pulmonary, uncontrolled hypertension and also pregnant women and breast‐feeding women, patients using antihyperlipidemic agents, steroids, Cigarette, alcohol were excluded. Intervention: Treatment group received the grind powder of Melissa officinalis and control group received placebo capsules at a dose of 3 gr daily (two 500mg capsules after every main course) by the oral route for 2 months. main outcome variables: At baseline and also the end of the study, the fasting (after at least fasting for 12 h) blood serum

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042017347N1
Registration date: 2014-08-25, 1393/06/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-25, 1393/06/03
Registrant information
Name
Parisa Jandaghi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7713 3836
Email address
jandaghi.parisa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Melissa Officinalis L. on Lipid Profile in Patients with Hyperlipidemia
Public title
The Effect of Melissa Officinalis on Serum Lipid Profile
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male and female outpatients aged 25 to 65 years; They had at least one of indices including Serum total cholesterol: 200 to 260 mg/dl; Serum low density lipoprotein: 100 to up mg/dl and Serum Triglycerides: 150 to 300 mg/dl; Body Mass Index (BMI) less than 40 Exclusion criteria: the patients who are in need of taking other antihyperlipidemic agents; patient with diabetes; coronary-vascular disease; renal; hepatic; hematological; pulmonary diseases; Uncontrolled hypertension; pregnant women; breast‐feeding women; women planning pregnancy; patients using antihyperlipidemic agents; steroids; Cigarette; alcohol; they who may suffer from undesirable complications over the study including headache; vertigo; Nausea and melissa officinalis intolerance; patients Unwillingness to cooperate with this study.
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid bahonar Boulevard, Qazvin,Iran
City
Qazvin
Postal code
3419759811
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
28.20.8098

Health conditions studied

1

Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified

Primary outcomes

1

Description
Lipid profile:Total cholesterol, Triglyceride, HDL-C, LDL-C
Timepoint
Baseline and after two months
Method of measurement
Biochemical Analysis

2

Description
Liver Enzymes: ALT, AST
Timepoint
Baseline and after two months
Method of measurement
Biochemical Analysis

3

Description
Thyroid Hormones: T3, T4, TSH
Timepoint
Baseline and after two months
Method of measurement
Biochemical Analysis

4

Description
Fasting Blood Suger
Timepoint
Baseline and after two months
Method of measurement
Biochemical Analysis

5

Description
Creatinine
Timepoint
Baseline and after two months
Method of measurement
Biochemical Analysis

Secondary outcomes

1

Description
Side Effect
Timepoint
Baseline and after two months
Method of measurement
Checklist

2

Description
Body Mass Index
Timepoint
Baseline and after two months
Method of measurement
Formula

3

Description
Pulse Rate
Timepoint
Baseline and after two months
Method of measurement
Baseline and after two months

4

Description
Blood Pressure
Timepoint
Baseline and after two months
Method of measurement
Baseline and after two months

Intervention groups

1

Description
Intervention Group: grind powder of melissa officinalis at a dose of 3 gr daily (two 500mg capsules after every main course) by the oral route for two months
Category
Treatment - Drugs

2

Description
Control Group: grind powder of corn starch at a dose of 3 gr daily (two 500mg capsuls after every main course) by the oral route for two months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ansari Hospital
Full name of responsible person
Parisa Jandaghi
Street address
Narmak Day and Night Clinic, 46 west Ave, Narmak area, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeeid Asef Zadeh
Street address
Qazvin University of Medical Sciences, Shadid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Mostafa Noroozi
Position
Associated Professor of Human Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, I.R. Iran
City
Qazvin
Postal code
3419759811
Phone
+98 28 2222 8034
Fax
Email
mnoroozi@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parisa Jandaghi
Position
MSc Student of Health Science in Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, I.R. Iran
City
Qazvin
Postal code
3419759811
Phone
+98 912 443 4620
Fax
Email
jandaghi.parisa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parisa Jandaghi
Position
MSc Student of Health Science in Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, I.R. Iran
City
Qazvin
Postal code
3419759811
Phone
00
Fax
Email
jandaghi.parisa@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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