The aim of this study is survey effect of black hawthorn supplements on serum glucose, lipid profile, insulin resistance in patients with type 2 diabetes. Inclusion criteria: willingness to cooperate, the risk of type 2 diabetes, not using insulin; BMI higher than 18.5 Exclusion criteria change the type and dose of drugs. The study population are 46 patients with type 2 diabetes. Patients in the intervention group receive Black hawthorn supplement and intervention group received placebo for 8 weeks daily. At the beginning and end of the study, serum glucose and total cholesterol will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101124473N1
Registration date:2016-02-05, 1394/11/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-05, 1394/11/16
Registrant information
Name
Leila Abedi Firizjai
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3243 3681
Email address
abedi.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of black hawthorn supplements on serum glucose, lipid profile, insulin resistance in patients with type 2 diabetes
Public title
Effect of black hawthorn supplements on serum glucose, lipid profile, insulin resistance in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to cooperate; the risk of type 2 diabetes; not using insulin; BMI higher than 18.5. Exclusion criterion: change the type and dose of drugs.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz
City
Ahvaz, Ahvaz Jundishapur University of Medical Sciences
Postal code
Approval date
2015-08-07, 1394/05/16
Ethics committee reference number
IR.AJUMS.REC.1394.362
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E10-14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Cholesterol
Timepoint
Before the intervention, after intervention
Method of measurement
Enzymatic method using kits
Secondary outcomes
1
Description
Glucose
Timepoint
Before the intervention, after intervention
Method of measurement
Enzymatic method using kits
Intervention groups
1
Description
Intervention group: black hawthorn supplement, 2 capsules of 400 mg, 2 times a day, for 8 weeks
Category
Treatment - Drugs
2
Description
control group: placebo, 2 capsules containing avicel powder, 2 times a day, for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Rohani Hospital
Full name of responsible person
Leila Abedi
Street address
Rohani Hospital, Babol, Mazandaran, IRAN
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical SciencesVice Chancellor for Research and Technology Developm
Full name of responsible person
Leila Abedi
Street address
Rohani Hospital, Babol, Mazandaran, IRAN
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical SciencesVice Chancellor for Research and Technology Developm
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Leila Abedi
Position
Masters student
Other areas of specialty/work
Street address
Rohani Hospital, Babol, Mazandaran, Iran
City
Babol
Postal code
Phone
+98 11 3243 3681
Fax
Email
leila.abedi7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Durdana Hosin
Position
PhD Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khozestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 3336 5071
Fax
Email
durdana532@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Leila Abedi
Position
Masters student
Other areas of specialty/work
Street address
City
Ahvaz
Postal code
Phone
+98 11 3243 3681
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)