Evaluation the effect of standardized ginseng extract Panaxs (G115 ®) on blood glucose levels, glycated hemoglobin and lipid profile in patients with diabetes type 2: double blind randomized placebo controlled trial
The aim of this study was to investigate the effect of standardized ginseng extract panax (G115) on glucose, glycosylated hemoglobin and lipid profile in patients with diabetes type 2.This study is a double blind randomized placebo controlled trial. Patients who have at least 40 years of age, use oral drug for controlling blood glucose, do not inject insulin and have not an allergy to ginseng will be enrolled randomly in 2 groups: ginseng extract and placebo. Fasting blood glucose, HBA1C, HDL, LDL, VLDL, TG and Cholesterol are measured before and 8 weeks after the intervention. Ginseng extract group will receive 300 mg of standardized ginseng extract three times a day and every time 100 mg, 30 minutes before breakfast, lunch and dinner. Placebo group will receive placebo capsule (1 gr of Wheat flour) in same protocol with the other group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103196090N1
Registration date:2012-09-04, 1391/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-04, 1391/06/14
Registrant information
Name
Reza Malihi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3050
Email address
r.malihi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-04-08, 1391/01/20
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of standardized ginseng extract Panaxs (G115 ®) on blood glucose levels, glycated hemoglobin and lipid profile in patients with diabetes type 2: double blind randomized placebo controlled trial
Public title
Evaluation the effect of standardized ginseng extract on blood glucose levels and lipid profile in patients with diabetes type 2.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Fasting blood glucose greater than or equal to 126 mg/dL; At least 40 years of age; At least two years of experience of type 2 diabetes; using oral drug for controlling blood glucose (metformin, glibenclamide); No history of other diseases (such as, cardiovascular, hepatic, renal and metabolic disorders); BMI 25 to 35. Exclusion criteria: Allergies to ginseng extract; ketonuria symptoms; need for insulin.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd
City
Ahvaz
Postal code
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
ETH-491
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Primary outcomes
1
Description
fasting blood glucose
Timepoint
before and after 8 weeks intervention
Method of measurement
mg/dl
2
Description
HBA1C %
Timepoint
before and after 8 weeks intervention
Method of measurement
percent of HBA1C
3
Description
lipid profiles
Timepoint
before and after 8 weeks intervention
Method of measurement
LDL,HDL.Chol,TG,VLDL
Secondary outcomes
1
Description
blood pressure
Timepoint
once every 2 weeks
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
ginseng extract group will receive 300 mg of standardized ginseng extract(G115) three times a day and every time 100 mg , 30 minutes before breakfast , lunch and dinner
Category
Other
2
Description
placebo group will receive placeb0(1g Wheat flour) three times a day and every time 100 mg , 30 minutes before breakfast , lunch and dinner
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital Clinic
Full name of responsible person
Dr. Ali Ehsanpour
Street address
Amaniyeh-Razi Hospital Clinic
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feqhi
Street address
Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Malihi
Position
student of MSc. of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences , Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
r.malihi@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Seyyed Ahmad Hosseini
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Ahvaz jundishapur university of medical sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
seyyedahmadhosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Reza Malihi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)