This study aim to investigating the effect of apple vinegar and honey combination on lowering the level of blood lipids and comparing its effect with the lipid -lowering drugs like Atorvastatin and Gemfibrozil. To this aim, the subjects of the study will be selected base on inclusion criteria and using convenience sampling and randomly divided into two groups of intervention and control after obtaining permission from the university and acquiring the participants’ informed consents. The study sample consists of 60 patients with increase levels of blood lipids(cholesterol, TG, LDL, HDL). For subsequent investigations, levels of blood lipids are measure at the beginning and 4 weeks after the intervention in both groups . The participants in the control group only receive their usual medication during this 4-week period, while those in the intervention group will be administered one tablespoon of honey and apple vinegar in a glass containing 200cc water twice a day in addition to their usual lipid-lowering drugs. After 4 weeks, levels of blood lipids are measure in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512206634N3
Registration date:2016-01-22, 1394/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Soleiman Zand
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3524
Email address
slmnzand@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center School of ARAK Nursing and Midwifery supplied.
Expected recruitment start date
2015-12-26, 1394/10/05
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The combined effect of apple vinegar and honey on blood lipids in patient with hyperlipidemia
Public title
The combined effect of apple vinegar and honey on blood lipids in patient with hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having high levels of blood lipids; over 20 and under 50 years of age; being conscious and able to communicate; having no experience of such training in other centers; using no herbal remedies effective for managing blood lipids.
Exclusion criteria: lack of consent to participate in the study; not being affected by gastric and duodenal ulcers; suffering from acute medical problems; suffering from mental health problems and addiction; simultaneous participation in another study interfering with the present one.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Arak University Of Medical Sciences
Street address
College Of Nursing And Midwifery, Sardasht Street,Arak
City
ARAk
Postal code
6941-7-38481
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
3-158-93
Health conditions studied
1
Description of health condition studied
Hyperglisiridemi
ICD-10 code
E78.1
ICD-10 code description
puar Haiperglyceridaemia
Primary outcomes
1
Description
Level fat in blood
Timepoint
First and four week later
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group will be administered one tablespoon each honey and apple vinegar in a glass containing 200cc water twice a dayin addition to their usual lipid-lowering drugs.
Category
Treatment - Drugs
2
Description
Control group:The participants in the control group only will be received their usual medication during this 4-week period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Educational And Remedial Center
Full name of responsible person
Ms Hajian Leila
Street address
Amiralmomenin Educational And Remedial Center, Sardasht Street, Arak, Iran
City
Amiralmomenin Educational And Remedial Center, Sardasht Street, Arak, Iran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research Medical University Of Arak
Full name of responsible person
Dr Rafii Mohammad
Street address
School Of Nursing And Midwifery Arak University Of Medical Sciences, Sardasht Street,Arak,Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research Medical University Of Arak
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
College Of Nursing & Midwifery, Sardasht Street, Arak
Full name of responsible person
Zand Soleiman
Position
Msc In Medical Education
Other areas of specialty/work
Street address
College Of Nursing & Midwifery, Sardasht Street, Arak
City
ARAK
Postal code
6941-7-38481
Phone
+98 86 3417 3524
Fax
Email
solaimanzand@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Siences
Full name of responsible person
Zand Soleiman
Position
Msc In Medical Education
Other areas of specialty/work
Street address
College Of Nursing & Midwifery, Sardasht Street, Arak
City
ARAK
Postal code
6941-7-38481
Phone
+98 86 3417 3524
Fax
Email
solaimanzand@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Siences
Full name of responsible person
Zand Soleiman
Position
MSC
Other areas of specialty/work
Street address
College Of Nursing & Midwifery, Sardasht Street, Arak
City
ARAK
Postal code
6941-7-38481
Phone
+98 86 3417 3524
Fax
+98 34173524
Email
solaimanzand@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)