Evaluation of the effect of Allium hirtifolium on serum levels of lipids
Design
Two arm parallel group, randomized, double-blind, controlled clinical trial
Settings and conduct
The study will be done in Isfahan cardiovascular research center. The selected patients will be randomly assigned to drug and placebo groups. Appropriate dietary regimen and maintaining physical activity will be recommended to two groups. Before the intervention, blood samples will be obtained from the patients of both groups and serum levels of lipids will be determined. At the end of intervention, these parameters will be measured again and recorded. Finally, the results of the two groups will be compared. The prescribing physician, laboratory staff, and data analyst will be blind to the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion critera: Age of more than 18 years; serum level of LDL between 100 to 160 mg/dL; having less than 2 cardiovascular risk factors
Exclusion criteria: Cardiac stable angina; diabetes mellitus; diseases affecting serum level of lipids; use of drugs affecting serum level of lipids
Intervention groups
Drug group: 500-mg oral capsules of Allium, twice daily, for 6 weeks
Placebo group: 500-mg oral capsules of placebo, twice daily, for 6 weeks
Main outcome variables
Serum levels of total cholesterol, TG, HDL, LDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N7
Registration date:2020-01-03, 1398/10/13
Registration timing:retrospective
Last update:2020-01-03, 1398/10/13
Update count:0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of allium hirtifolium on serum lipid profile in adult patients with hyperlipidemia
Public title
Evaluation the effect of allium hirtifolium in the treatment of hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of more than 18 years
Serum level of LDL between 100 to 160 mg/dL
Having less than 2 cardiovascular risk factors
Exclusion criteria:
Cardiac stable angina
Diabetes mellitus
Diseases affecting level of serum lipids
Use of drugs affecting level of serum lipids
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: Blocks of 4 will be used and patients will be assigned to drug and placebo groups based on the determined sequences in the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and placebo capsules will be fully similar and packaged in similar containers. The patient, the prescriber (physician), data analyst, and the laboratory personnel will be blind to the content of containers and intervention type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar-Jerib Avenue, Vice-chancellery for research, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.291
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
Serum level of total cholesterol
Timepoint
Before the intervention and the end of intervention (6 weeks after the start of intervention)
Method of measurement
Blood test
2
Description
Serum level of triglycerides
Timepoint
Before the intervention and the end of intervention (6 weeks after the start of intervention)
Method of measurement
Blood test
3
Description
Serum level of LDL
Timepoint
Before the intervention and the end of intervention (6 weeks after the start of intervention)
Method of measurement
Blood test
4
Description
Serum level of HDL
Timepoint
Before the intervention and the end of intervention (6 weeks after the start of intervention)
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Drug group: 500-mg oral capsules of Allium, twice daily, for 6 weeks
Category
Treatment - Drugs
2
Description
Placebo group: 500-mg oral capsules of placebo, twice daily, for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Institute
Full name of responsible person
Rasool Soltani
Street address
Third Moshtagh
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3611 5313
Email
soltani@pharm.mui.ac.ir
Web page address
https://icri.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-83461
Phone
+98 31 3668 0048
Email
soltani@pharm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 20, Bagh Daryacheh Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 20, Bagh Daryacheh Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 20, Bagh Daryacheh Ave.
City
Esfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
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