Protocol summary

Summary
In recent years, with socioeconomic development, changes in lifestyle, diet and the aging of the population, the incidence of hyperlipidemia has been increased. Actually, it is one of the most important public health problems which threats human health worldwide and is associated with excessive medical expenses. Hyperlipidemia is an asymptomatic chronic condition commonly characterized by an excess of lipid profiles in the bloodstream, it can silently hurt the blood vessels, heart, brain, and kidneys. Thus, these patients have a significant and recognized risk factor for progression of atherosclerosis, cardiovascular and cerebrovascular diseases. Cholesterol is a fatty substance which is circulate in the blood and has an essential role in the body as protection for the vascular walls, linings of body organs, digestive function and a component in forming cell membranes and some hormones. But, it can also be a problem, if too much used through the diet and not metabolized or used. High level of cholesterol has been shown to destroy vascular function and structure and leading to accumulation of fatty plaques on vessel walls, narrowing veins and arteries and decreased blood flow to the heart muscle, brain, and other organs or leading to embolism. In addition, high cholesterol cause to oxidative change, which has an augmentative role in the formation of atheroma plaques in vessels wall. Generally, hyperlipidemia diagnosed by confirmed in individuals with blood cholesterol levels of >200 mg/dl or blood triglyceride levels of >180 mg/dl. Controlling hyperlipidemia also have a vital role in the prevention of hypertension, myocardial infarction, risk of stroke, coronary deaths, and overall mortality. Although, a healthy lifestyle, weight loss, and decreased dietary cholesterol have been shown to lower the risk of developing hyperlipidemia. If these interventions are not efficient, drug therapy will be necessary in decreasing hyperlipidemia. Many anticholinergic adverse effects such as weight gain or weight loss, nausea, constipation, sedation, cardiac toxicity, orthostatic hypotension, arrhythmias, sexual dysfunction and many drug interactions may occur with antihyperlipidemic medicines. At the present years, the interest for herbal remedies as an important factor for treatment and maintenance of health is increasingly emphasized. The use of herbal remedies becomes wide spread in the world due to their low expense, availability, less side effects and drug interactions compared to the chemical drugs. Lactuca sativa commonly known as lettuce, is a plant species belonging to the family Asteraceae. It is most often grown as a leaf vegetable and sometimes for its stem and seeds. It is a very popular herb for salad and food. In recent pharmacological studies, lettuce has demonstrated antidiabetic, narcotic, antioxidant and anti-inflammatory activities. Phenolic acids, flavonoids, anthocyanins, and vitamins A and C are the major active compounds in lettuce. Some well-designed clinical trials have indicated the efficacy of lettuce in sleep disorder, anxiety and diabet. In this study, we investigated the hypolipidemic effect of chronic administration of aqueous ethanol extract of lettuce seed in a 12-week double-blind, placebo-controlled and randomized clinical trial. The data suggested that lettuce extract has hypolipidemic properties and should be further investigated as a potential intervention for hyperlipidemic treatment in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011213058N5
Registration date: 2016-10-25, 1395/08/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-25, 1395/08/04
Registrant information
Name
Seyed Ahmad Mohajeri
Name of organization / entity
Pharmaceutical Research Center, School Of Pharmacy, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohajeria@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of hydroalcoholic extract of lettuce seed on lipid profile in hyperlipidemic patients: a randomized double blind clinical trial
Public title
The effect of lettuce seed on hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male and female outpatients aged 25 to 65 years; incidence of hyperlipidemia with at least one of the following factors related to cholesterol > 200 mg/dl; TG> 150 mg / dl; LDL> 130 mg/dl; HDL<40 mg/dl. The exclusion criteria: the patients who had underlying diseases such as diabetes; IHD; hypertension; metabolic syndrome; peripheral vascular disease; coronary artery disease; LDL more than 190 in patients who needs medical treatment (for healthy people or with one risk factor); LDL ≥ 160 in patients they need drug treatment (for those with two or more risk factors). Risk Factors: smoking; hypertension; low HDL level (less than 40); history of coronary artery disease at an early age in the household (less than 55 years in males and in females under age 65years old).
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Qoreishi Building, Daneshgah Street, Mashhad, Iran
City
Mashhad
Postal code
91388-13944
Approval date
2016-02-06, 1394/11/17
Ethics committee reference number
IR.MUMS.REC.1394.614

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
Cholestrol, Tg, HDL, LDL
Timepoint
Baseline, after 6th week, after 12th week
Method of measurement
Blood test

2

Description
BMI
Timepoint
Every 2 weeks
Method of measurement
Height/ weight

Secondary outcomes

1

Description
Side effects
Timepoint
Every 2 weeks
Method of measurement
Questionair

Intervention groups

1

Description
Intervention group: Prescription of lettuce seed capsules (1000mg/ day) plus atorvastatin tablet (20mg/day) in hyperlipidemic patients for 12 weeks. Participants did not receive any other hypolipidemic drugs during the trial. The patients compliance and medication side effect were estimated at each visit.
Category
Treatment - Drugs

2

Description
Control group: prescription of placebo capsules (1000mg/ day) plus Atorvastatin tablet (20mg/day) in hyperlipidemic patients for12 week. Participants did not receive any other hypocholestrolemic drugs during the trial. The patients compliance and medication side effect were estimated at each visit.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bekran Health Center
Full name of responsible person
Maryam Hassanpour Moghadam
Street address
Shahroud road (km 80), miamey
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Ahmad Mohajeri
Street address
Faculty of Pharmacy
City
Mashhad
Grant name
Grant code / Reference number
940704
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Ahmad Mohajeri
Position
PhD, Pharm D
Other areas of specialty/work
Street address
Faculty of Pharmacy
City
Mashhad
Postal code
Phone
+98 51 3711 2611
Fax
+51 37112470
Email
mohajeria@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Ahmad Mohajeri
Position
Phd, Pharm D
Other areas of specialty/work
Street address
Faculty of Pharmacy
City
Mashhad
Postal code
Phone
+98 51 3711 2611
Fax
+98 51 3711 2470
Email
mohajeria@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Maryam Hassanpour Moghadam
Position
MD.
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
+98 51 3882 3251
Email
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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